Effect of Prewarming On Skin Temperature Changes
Primary Purpose
Spinal Anesthesia, Hypothermia Following Anesthesia, Prewarming
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation
Sponsored by
About this trial
This is an interventional other trial for Spinal Anesthesia focused on measuring hypothermia, peripheral temperature, spinal anesthesia, forced-air warming
Eligibility Criteria
Inclusion Criteria:
- ASA I-II-III
- 50-80 years old
- Patients scheduled for transurethral baldder resection
Exclusion Criteria:
- Female gender
- Uncoordinated patients
- Have coagulopathy,
- Known allergies to drugs to be used,
- Patients diagnosed with severe hypovolemia
- Skin infection at the injection site.
- Body mass index greater than 35m2/kg
- patients with severe endocrinological disease
- Patients with cardiovascular diseases
- patients with severe aortic stenosis or severe mitral stenosis
- patients with increased intracranial pressure
Sites / Locations
- Bozyaka Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Prewarmed group
Arm Description
Patients covered with a 41 centigrade degrees double layered cotton cloth
Patients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation
Outcomes
Primary Outcome Measures
peripheral skin temperature at ( F0)
F0 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S0)
S0 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( T0)
T0 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M0)
M0 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( F1)
F1will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F2)
F2 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F3)
F3 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F4)
F4 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F5)
F5 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F6)
F6 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F7)
F7 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F8)
F8 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F9)
F9 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F10)
F10 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F15)
F15 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F20)
F20 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F25)
F25 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F30)
F30 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F35)
F35 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F40)
F40 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F45)
F45 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F50)
F50 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F55)
F55 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F60)
F60 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S1)
S1 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S2)
S2 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S3)
S3 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S4)
S4 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S5)
S5 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S6)
S6 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S7)
S7 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S8)
S8 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S9)
S9 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S10)
S10 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S15)
S15 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S20)
S20 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S25)
S25 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S30)
S30 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S35)
S35 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S40)
S40 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S45)
S45 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S50)
S50 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S55)
S55 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S60)
S60 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( T1)
T1 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T2)
T2 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T3)
T3 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T4)
T4 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T5)
T5 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T6)
T6 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T7)
T7 will be defined as temperature which measured at L5 deramatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T8)
T8 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T9)
T9 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T10)
T10 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T15)
T15 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T20)
T20 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T25)
T25 will be defined as temperature which measured L5 dermatome at plantar side of 1st toe with adult skin probe
peripheral skin temperature( T30)
T30 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T35)
T35 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T40)
T40 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T45)
T45will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T50)
T50 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T55)
T55 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T60)
T60 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M1)
M1 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M2)
M2 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M3)
M3 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M4)
M4 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M5)
M5 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M6)
M6 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M7)
M7 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M8)
M8 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M9)
M9 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M10)
M10 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M15)
M15 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M20)
M20 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M25)
M25 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M30)
M30 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M35)
M35 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M40)
M40 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M45)
M45 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M50)
M50 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M55)
M55 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M60)
M60 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Secondary Outcome Measures
core tympanic membrane temperature (C0)
centigrade degree , Timpanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
core tympanic membrane temperature(C1)
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
core tympanic membrane temperature(C2)
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
core tympanic membrane temperature(C3)
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
core tympanic membrane temperature(C4)
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
thermal comfort scale
thermal comfort will be rated on a 100mm visual analog scale (VAS),with zero indicating intense cold and 100mm representing intense heat
shivering score(h0)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
shivering score(h1)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
shivering score(h2)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
shivering score(h3)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
shivering score(h4)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
shivering score(h5)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
shivering score(h6)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
shivering score(h7)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
shivering score(h8)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Full Information
NCT ID
NCT05063292
First Posted
August 31, 2021
Last Updated
September 27, 2021
Sponsor
Bozyaka Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05063292
Brief Title
Effect of Prewarming On Skin Temperature Changes
Official Title
Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2021 (Anticipated)
Primary Completion Date
November 10, 2021 (Anticipated)
Study Completion Date
November 18, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozyaka Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups. First group will be covered with 41 centigrade degrees double layered cotton cloth. Second group will receive active prewarming. Core temperature of all patients will be monitorized via tympanic membrane. Skin temperature will be monitorized from 4 different body areas. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. Hemodynamic parameters will be recorded. Skin temperature will be monitorized before and after spinal anesthesia and changes will be recorded. Operation time, amount and temperature of irrigation fluids, transfusion requirement, discharge time from postoperative care unit will also be recorded. Shivering score and thermal comfort scale will be used. The two groups will be compared for the temperature changes.
Detailed Description
In this prospective single-blind study, patients will be divided into 2 groups with computer-based randomization technique. All patients will have a fasting time of 2 hours for clear fluid and 6 hours for solid food. Patients will be taken to the premedication room before the operation. Written and verbal approval will be taken from all patients. Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer,every 15 minutes.Adult skin temperature probe will be used for continuous peripheral temperature measurement from four different body areas (T1:Cervical7 (C7) dermatome, T2:C6 dermatome T3:Lumbar 5( L5 )dermatome, T4: L4 dermatome). The two groups will have an infusion of balanced electrolyte solution with a rate of 8 Mililitre/Kilogram/ hour(mL/kg/hour). Patients in Group I will be covered with a 41 centigrade degrees double layered cotton clothes. Patients in Group II will receive active prewarming with a forced-air warming blanket (WarmCare full body blanket) 30 minutes prior to the operation. 0.1 mg/kg intravenous (iv) midazolam hydrochloride will be administered for premedication. Patients will be transferred to operating room, covered with warmed double layered cotton clothes. Standard monitoring (pulse oximetry, noninvasive blood pressure, electrocardiography) will be applied to the patients. Core temperature and 4-points skin temperature measurements will be recorded. Patients will be delivered 2 Liter/minute oxygen with a nasal cannula. Iv hydration will be continued by room temperature balanced electrolyte solution with an infusion rate of 2mililiter/kilogram/hour. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position. Then patients will be taken supine position. Hemodynamic measurements will be continued. Core temperature measurements will be done every 15 minutes. Peripheral skin temperature measurements will be continuous. 1st, 2nd ,3rd,4th ,5th ,6th, 7th, 8th, 9th and 10th minutes and every 5 minutes measurements will be recorded during the operation. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. The time for adequate sensorial block (T10) will be recorded. The patients will be repositioned (lithotomy) before the beginning of surgery. 5 mg iv ephedrine and 0.5 mg iv atropine will be administered when the blood pressure will be %80 of the baseline pressure and heart rate. Operating time, amount and temperature of irrigation fluids, transfusion requirement will be recorded. All patients will be transferred to post anesthesia care unit (PACU). Core temperature measurements will be continued every 15 minutes at PACU. Shivering scale and thermal comfort scale will be used during and after the operation. 25 mg iv meperidine will be administered when the patient's shivering score will be more than 3. Length of PACU stay will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Anesthesia, Hypothermia Following Anesthesia, Prewarming, Core Temperature, Urological Cancer
Keywords
hypothermia, peripheral temperature, spinal anesthesia, forced-air warming
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study covers 2 groups. Group I will be covered with warmed double layered cotton cloth. Group II will be covered with air forced blanket.
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients covered with a 41 centigrade degrees double layered cotton cloth
Arm Title
Prewarmed group
Arm Type
Experimental
Arm Description
Patients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation
Intervention Type
Procedure
Intervention Name(s)
Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation
Intervention Description
Core temperature and 4-points skin temperatures measurements will be recorded all over the operation. Patients will be delivered 2 Litre/minute oxygen with a nasal cannula.Iv hydration will be continued by room temperatured balanced electrolyte solution with an infusion rate of 2mL/kg/hr. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position.
Primary Outcome Measure Information:
Title
peripheral skin temperature at ( F0)
Description
F0 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
just after spinal anesthesia done
Title
peripheral skin temperature at( S0)
Description
S0 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
just after spinal anesthesia done
Title
peripheral skin temperature( T0)
Description
T0 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
just after spinal anesthesia done
Title
peripheral skin temperature( M0)
Description
M0 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
just after spinal anesthesia done
Title
peripheral skin temperature( F1)
Description
F1will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
60 seconds after spinal anesthesia done
Title
peripheral skin temperature( F2)
Description
F2 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
120 seconds after spinal anesthesia done
Title
peripheral skin temperature( F3)
Description
F3 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
180 seconds after spinal anesthesia done
Title
peripheral skin temperature( F4)
Description
F4 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
4 minute after spinal anesthesia done
Title
peripheral skin temperature( F5)
Description
F5 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
5 minute after spinal anesthesia done
Title
peripheral skin temperature( F6)
Description
F6 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
6 minute after spinal anesthesia done
Title
peripheral skin temperature( F7)
Description
F7 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
7 minute after spinal anesthesia done
Title
peripheral skin temperature( F8)
Description
F8 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
8 minute after spinal anesthesia done
Title
peripheral skin temperature( F9)
Description
F9 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
9 minute after spinal anesthesia done
Title
peripheral skin temperature( F10)
Description
F10 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
10 minute after spinal anesthesia done
Title
peripheral skin temperature( F15)
Description
F15 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
15 minute after spinal anesthesia done
Title
peripheral skin temperature( F20)
Description
F20 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
20 minute after spinal anesthesia done
Title
peripheral skin temperature( F25)
Description
F25 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
25 minute after spinal anesthesia done
Title
peripheral skin temperature( F30)
Description
F30 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
30 minute after spinal anesthesia done
Title
peripheral skin temperature( F35)
Description
F35 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
35 minute after spinal anesthesia done
Title
peripheral skin temperature( F40)
Description
F40 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
40 minute after spinal anesthesia done
Title
peripheral skin temperature( F45)
Description
F45 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
45 minute after spinal anesthesia done
Title
peripheral skin temperature( F50)
Description
F50 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
50 minute after spinal anesthesia done
Title
peripheral skin temperature( F55)
Description
F55 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
55 minute after spinal anesthesia done
Title
peripheral skin temperature( F60)
Description
F60 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Time Frame
60 minute after spinal anesthesia done
Title
peripheral skin temperature at( S1)
Description
S1 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
60 seconds after spinal anesthesia done
Title
peripheral skin temperature at( S2)
Description
S2 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
120 seconds after spinal anesthesia done
Title
peripheral skin temperature at( S3)
Description
S3 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
180 seconds after spinal anesthesia done
Title
peripheral skin temperature at( S4)
Description
S4 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
4 minute after spinal anesthesia done
Title
peripheral skin temperature at( S5)
Description
S5 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
5 minute after spinal anesthesia done
Title
peripheral skin temperature at( S6)
Description
S6 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
6 minute after spinal anesthesia done
Title
peripheral skin temperature at( S7)
Description
S7 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
7 minute after spinal anesthesia done
Title
peripheral skin temperature at( S8)
Description
S8 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
8 minute after spinal anesthesia done
Title
peripheral skin temperature at( S9)
Description
S9 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
9 minute after spinal anesthesia done
Title
peripheral skin temperature at( S10)
Description
S10 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
10 minute after spinal anesthesia done
Title
peripheral skin temperature at( S15)
Description
S15 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
15 minute after spinal anesthesia done
Title
peripheral skin temperature at( S20)
Description
S20 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
20 minute after spinal anesthesia done
Title
peripheral skin temperature at( S25)
Description
S25 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
25 minute after spinal anesthesia done
Title
peripheral skin temperature at( S30)
Description
S30 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
30 minute after spinal anesthesia done
Title
peripheral skin temperature at( S35)
Description
S35 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
35 minute after spinal anesthesia done
Title
peripheral skin temperature at( S40)
Description
S40 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
40 minute after spinal anesthesia done
Title
peripheral skin temperature at( S45)
Description
S45 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
45 minute after spinal anesthesia done
Title
peripheral skin temperature at( S50)
Description
S50 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
50 minute after spinal anesthesia done
Title
peripheral skin temperature at( S55)
Description
S55 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
55 minute after spinal anesthesia done
Title
peripheral skin temperature at( S60)
Description
S60 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Time Frame
60 minute after spinal anesthesia done
Title
peripheral skin temperature( T1)
Description
T1 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
60 seconds after spinal anesthesia done
Title
peripheral skin temperature( T2)
Description
T2 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
120 seconds after spinal anesthesia done
Title
peripheral skin temperature( T3)
Description
T3 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
180 seconds after spinal anesthesia done
Title
peripheral skin temperature( T4)
Description
T4 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
4 minute after spinal anesthesia done
Title
peripheral skin temperature( T5)
Description
T5 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
5 minute after spinal anesthesia done
Title
peripheral skin temperature( T6)
Description
T6 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
6 minute after spinal anesthesia done
Title
peripheral skin temperature( T7)
Description
T7 will be defined as temperature which measured at L5 deramatome plantar side of 1st toe with adult skin probe
Time Frame
7 minute after spinal anesthesia done
Title
peripheral skin temperature( T8)
Description
T8 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
8 minute after spinal anesthesia done
Title
peripheral skin temperature( T9)
Description
T9 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
9 minute after spinal anesthesia done
Title
peripheral skin temperature( T10)
Description
T10 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
10 minute after spinal anesthesia done
Title
peripheral skin temperature( T15)
Description
T15 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
15 minute after spinal anesthesia done
Title
peripheral skin temperature( T20)
Description
T20 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
20 minute after spinal anesthesia done
Title
peripheral skin temperature( T25)
Description
T25 will be defined as temperature which measured L5 dermatome at plantar side of 1st toe with adult skin probe
Time Frame
25 minute after spinal anesthesia done
Title
peripheral skin temperature( T30)
Description
T30 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
30 minute after spinal anesthesia done
Title
peripheral skin temperature( T35)
Description
T35 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
35 minute after spinal anesthesia done
Title
peripheral skin temperature( T40)
Description
T40 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
40 minute after spinal anesthesia done
Title
peripheral skin temperature( T45)
Description
T45will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
45 minute after spinal anesthesia done
Title
peripheral skin temperature( T50)
Description
T50 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
50 minute after spinal anesthesia done
Title
peripheral skin temperature( T55)
Description
T55 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
55 minute after spinal anesthesia done
Title
peripheral skin temperature( T60)
Description
T60 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Time Frame
60 minute after spinal anesthesia done
Title
peripheral skin temperature( M1)
Description
M1 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
60 seconds after spinal anesthesia done
Title
peripheral skin temperature( M2)
Description
M2 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
120 seconds after spinal anesthesia done
Title
peripheral skin temperature( M3)
Description
M3 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
180 seconds after spinal anesthesia done
Title
peripheral skin temperature( M4)
Description
M4 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
4 minute after spinal anesthesia done
Title
peripheral skin temperature( M5)
Description
M5 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
5 minute after spinal anesthesia done
Title
peripheral skin temperature( M6)
Description
M6 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
6 minute after spinal anesthesia done
Title
peripheral skin temperature( M7)
Description
M7 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
7 minute after spinal anesthesia done
Title
peripheral skin temperature( M8)
Description
M8 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
8 minute after spinal anesthesia done
Title
peripheral skin temperature( M9)
Description
M9 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
9 minute after spinal anesthesia done
Title
peripheral skin temperature( M10)
Description
M10 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
10 minute after spinal anesthesia done
Title
peripheral skin temperature( M15)
Description
M15 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
15 minute after spinal anesthesia done
Title
peripheral skin temperature( M20)
Description
M20 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
20 minute after spinal anesthesia done
Title
peripheral skin temperature( M25)
Description
M25 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
25 minute after spinal anesthesia done
Title
peripheral skin temperature( M30)
Description
M30 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
30 minute after spinal anesthesia done
Title
peripheral skin temperature( M35)
Description
M35 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
35 minute after spinal anesthesia done
Title
peripheral skin temperature( M40)
Description
M40 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
40 minute after spinal anesthesia done
Title
peripheral skin temperature( M45)
Description
M45 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
45 minute after spinal anesthesia done
Title
peripheral skin temperature( M50)
Description
M50 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
50 minute after spinal anesthesia done
Title
peripheral skin temperature( M55)
Description
M55 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
55 minute after spinal anesthesia done
Title
peripheral skin temperature( M60)
Description
M60 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Time Frame
60 minute after spinal anesthesia done
Secondary Outcome Measure Information:
Title
core tympanic membrane temperature (C0)
Description
centigrade degree , Timpanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Time Frame
just before spinal anesthesia done
Title
core tympanic membrane temperature(C1)
Description
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Time Frame
15 minute after spinal anesthesia done
Title
core tympanic membrane temperature(C2)
Description
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Time Frame
30 minute after spinal anesthesia done
Title
core tympanic membrane temperature(C3)
Description
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Time Frame
45 minute after spinal anesthesia done
Title
core tympanic membrane temperature(C4)
Description
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Time Frame
60 minute after spinal anesthesia done
Title
thermal comfort scale
Description
thermal comfort will be rated on a 100mm visual analog scale (VAS),with zero indicating intense cold and 100mm representing intense heat
Time Frame
Immediately after the surgery
Title
shivering score(h0)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
just before spinal anesthesia done
Title
shivering score(h1)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
15 minute after spinal anesthesia done
Title
shivering score(h2)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
30 minute after spinal anesthesia done
Title
shivering score(h3)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
45 minute after spinal anesthesia done
Title
shivering score(h4)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
60 minute after spinal anesthesia done
Title
shivering score(h5)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
75 minute after spinal anesthesia done
Title
shivering score(h6)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
90 minute after spinal anesthesia done
Title
shivering score(h7)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
105 minute after spinal anesthesia done
Title
shivering score(h8)
Description
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Time Frame
120 minute after spinal anesthesia done
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients scheduled for transurethral bladder resection
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II-III
50-80 years old
Patients scheduled for transurethral baldder resection
Exclusion Criteria:
Female gender
Uncoordinated patients
Have coagulopathy,
Known allergies to drugs to be used,
Patients diagnosed with severe hypovolemia
Skin infection at the injection site.
Body mass index greater than 35m2/kg
patients with severe endocrinological disease
Patients with cardiovascular diseases
patients with severe aortic stenosis or severe mitral stenosis
patients with increased intracranial pressure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Negin Nayebi, MD
Phone
+905541491707
Email
negin.naebi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zeki Tuncel Tekgül, Assoc Prof
Phone
+905058554705
Email
zekitekgul@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halide Hande Şahinkaya, Specialist
Organizational Affiliation
Izmir Bozyaka Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bozyaka Training and Research Hospital
City
İzmir
State/Province
Karabağlar
ZIP/Postal Code
35170
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29938773
Citation
Hermanns H, Werdehausen R, Hollmann MW, Stevens MF. Assessment of skin temperature during regional anaesthesia-What the anaesthesiologist should know. Acta Anaesthesiol Scand. 2018 Oct;62(9):1280-1289. doi: 10.1111/aas.13176. Epub 2018 Jun 25.
Results Reference
background
PubMed Identifier
30579334
Citation
Jun JH, Chung MH, Kim EM, Jun IJ, Kim JH, Hyeon JS, Lee MH, Lee HS, Choi EM. Effect of pre-warming on perioperative hypothermia during holmium laser enucleation of the prostate under spinal anesthesia: a prospective randomized controlled trial. BMC Anesthesiol. 2018 Dec 22;18(1):201. doi: 10.1186/s12871-018-0668-4.
Results Reference
background
PubMed Identifier
19996770
Citation
Fradkin AJ, Zazryn TR, Smoliga JM. Effects of warming-up on physical performance: a systematic review with meta-analysis. J Strength Cond Res. 2010 Jan;24(1):140-8. doi: 10.1519/JSC.0b013e3181c643a0.
Results Reference
background
PubMed Identifier
11137413
Citation
Frank SM, El-Rahmany HK, Tran KM, Vu B, Raja SN. Comparison of lower extremity cutaneous temperature changes in patients receiving lumbar sympathetic ganglion blocks versus epidural anesthesia. J Clin Anesth. 2000 Nov;12(7):525-30. doi: 10.1016/s0952-8180(00)00207-5.
Results Reference
background
PubMed Identifier
26571323
Citation
Jo YY, Chang YJ, Kim YB, Lee S, Kwak HJ. Effect of Preoperative Forced-Air Warming on Hypothermia in Elderly Patients Undergoing Transurethral Resection of the Prostate. Urol J. 2015 Nov 14;12(5):2366-70.
Results Reference
background
Learn more about this trial
Effect of Prewarming On Skin Temperature Changes
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