Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia
Primary Purpose
Body Temperature Changes, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Midazolam
Propofol
Standard
SpotOn
Sponsored by
About this trial
This is an interventional supportive care trial for Body Temperature Changes
Eligibility Criteria
Inclusion Criteria:
- Scheduled for orthopedic surgery of the foot or knee
- Indication to neuraxial anesthesia
- Surgery duration > 30 minutes
Exclusion Criteria:
- Preference for deep sedation
- Preference for no sedation
- Kidney failure
- Hepatic failure
- No signed informed consent
Sites / Locations
- Hospital da Luz
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Midazolam Group
Propofol group
Arm Description
In the "midazolam group" the investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.
In the "propofol group" the investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol TCI pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.
Outcomes
Primary Outcome Measures
Mean temperature
Comparison between the mean temperature in the two groups
Secondary Outcome Measures
Level of sensory block, T1-12/L1-5, assessed by a blunted needle
Top dermatome of sensory block, evaluated with a blunt needle
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02502877
Brief Title
Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia
Official Title
Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital da Luz, Portugal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study is a pilot study aiming to compare the variation in core temperature (measured through the non-invasive device Spot-OnTM3MTM) in patients submitted to neuraxial anesthesia for orthopedic procedures, during sedation with midazolam vs propofol.
Detailed Description
In this study the investigators will select 20 patients scheduled for orthopedic surgery of the knee or foot with neuraxial anesthesia (subarachnoid or sequential blocks). Sedation for these procedures with midazolam or propofol is daily practice in the investigators' department.
So the patients will be randomized, through the envelope method, in 2 groups with 10 patients each: "midazolam group" and "propofol group".
In the "midazolam group" the investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.
In the "propofol group" the investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol target-controlled infusion (TCI) pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.
The neuraxial block will be performed inside the operating room and preferentially in lateral decubitus. The choice of drug and dosage used for the block will be left to the anesthesiologist, to mimetize day-to-day practice. The limit dermatome of sensory block will be noted.
The investigators will administer to every patient: cefazolin 2g iv bolus, ketorolac 30 mg iv bolus, pantoprazole 40 mg iv bolus, paracetamol 1g iv perfusion (initiated 30 minutes before the end of surgery).
Central temperature will be monitored with the SpotOnTM3MTM device from entering till leaving the operating room, through a sensor placed in the patient's forehead. Room temperature will be kept at 17 degrees Celsius (ºC). Patients will be warmed with a underbody forced-air blanket (BairHuggerTM3MTM) set at 38ºC and maximal flow, initiated after performing the neuraxial block and stopped right before leaving the operating room.
Data will be analyzed with the Statistical Package for the Social Sciences (SPSS) program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Temperature Changes, Anesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Midazolam Group
Arm Type
Other
Arm Description
In the "midazolam group" the investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.
Arm Title
Propofol group
Arm Type
Active Comparator
Arm Description
In the "propofol group" the investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol TCI pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
A
Intervention Description
The investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
B
Intervention Description
The investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol TCI pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Standard
Intervention Description
The investigators will administer to every patient: cefazolin 2g iv bolus, ketorolac 30 mg iv bolus, pantoprazole 40 mg iv bolus, paracetamol 1g iv perfusion (initiated 30 minutes before the end of surgery).
Intervention Type
Device
Intervention Name(s)
SpotOn
Intervention Description
Central temperature will be monitored with the SpotOnTM3MTM device from entering till leaving the operating room, through a sensor placed in the patient's forehead
Primary Outcome Measure Information:
Title
Mean temperature
Description
Comparison between the mean temperature in the two groups
Time Frame
From entering the operating room up to cutaneous closure, an expected average of 1 to 1.5 hours
Secondary Outcome Measure Information:
Title
Level of sensory block, T1-12/L1-5, assessed by a blunted needle
Description
Top dermatome of sensory block, evaluated with a blunt needle
Time Frame
From 5 to 10 minutes after the performance of the neuraxial block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for orthopedic surgery of the foot or knee
Indication to neuraxial anesthesia
Surgery duration > 30 minutes
Exclusion Criteria:
Preference for deep sedation
Preference for no sedation
Kidney failure
Hepatic failure
No signed informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Gouveia, Dr.
Organizational Affiliation
Hospital da Luz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital da Luz
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
12. IPD Sharing Statement
Citations:
PubMed Identifier
25603202
Citation
Sun Z, Honar H, Sessler DI, Dalton JE, Yang D, Panjasawatwong K, Deroee AF, Salmasi V, Saager L, Kurz A. Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air. Anesthesiology. 2015 Feb;122(2):276-85. doi: 10.1097/ALN.0000000000000551.
Results Reference
background
PubMed Identifier
25045862
Citation
Eshraghi Y, Nasr V, Parra-Sanchez I, Van Duren A, Botham M, Santoscoy T, Sessler DI. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014 Sep;119(3):543-549. doi: 10.1213/ANE.0000000000000319.
Results Reference
background
PubMed Identifier
22187253
Citation
Jeong CW, Ju J, Lee DW, Lee SH, Yoon MH. Lipid-emulsion propofol less attenuates the regulation of body temperature than micro-emulsion propofol or sevoflurane in the elderly. Yonsei Med J. 2012 Jan;53(1):198-203. doi: 10.3349/ymj.2012.53.1.198.
Results Reference
background
PubMed Identifier
25693138
Citation
Iden T, Horn EP, Bein B, Bohm R, Beese J, Hocker J. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):387-91. doi: 10.1097/EJA.0000000000000232. Erratum In: Eur J Anaesthesiol. 2015 Oct;32(10):747.
Results Reference
background
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Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia
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