Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia
Primary Purpose
Lower Extremity Problem, Gynecologic Disease, Urinary Tract Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
Remimazolam
Sponsored by
About this trial
This is an interventional prevention trial for Lower Extremity Problem
Eligibility Criteria
Inclusion Criteria:
- Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
- American Society of Anesthesiologists' physical status class (ASA) award class I-III.
Exclusion Criteria:
- Patients with fever before surgery
- Patients taking antipyretics before surgery
- Patients who are chronically using anti-inflammatory drugs
- High-risk patients with ASA class IV or higher
- Patient who refused sedation
- Patients with thyroid dysfunction.
Sites / Locations
- Wonkwag UH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group P
Group R
Arm Description
The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).
The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).
Outcomes
Primary Outcome Measures
The incidence of perioperartive hypothermia
Measure the body temperature on the tympanic membrane three times and enter the highest value.
The incidence of perioperartive hypothermia
measure the body temperature three times on the tympanic membrane and enter the highest value.
Secondary Outcome Measures
core body temperature
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
core body temperature
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
core body temperature
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
shivering grades
None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall
Mild (Grade 1): shivering localized to the neck and/or thorax only
Moderate (Grade 2): shivering involved the gross movement of the upper extremities (in addition to neck and thorax)
Severe (Grade 3): shivering involved gross trunk and upper and lower extremities movements.
shivering grades
None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall
Mild (Grade 1): shivering localized to the neck and/or thorax only
Moderate (Grade 2): shivering involved the gross movement of the upper extremities (in addition to neck and thorax)
Severe (Grade 3): shivering involved gross trunk and upper and lower extremities movements.
Full Information
NCT ID
NCT05574257
First Posted
October 4, 2022
Last Updated
October 6, 2022
Sponsor
Wonkwang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05574257
Brief Title
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia
Official Title
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia: A Randomized Control Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonkwang University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
After dividing the patients into two groups, sedation is performed with propofol and remimazolam, respectively, after spinal anesthesia. Compare the patient's body temperature change after surgery.
Detailed Description
Patients in the study were randomly assigned to the propofol group (Group P) and the remimazolam group (Group R) in a 1:1 ratio. Study drugs are prepared in the same 50 ml syringe, double-blind to group assignment. All patients are not given pre-anesthetic medication, and body temperature, blood pressure, and heart rate are measured in the recovery room after surgery at 10-minute intervals from just before anesthesia induction to surgery. If hypotension or bradycardia occurs during surgery and is not corrected even after rapid fluid infusion, ephedrine is increased by 10 mg or glycopyrrolate 0.2 mg or atropine 0.5 mg is administered.
If spinal anesthesia is successfully performed, check the patient's anesthesia height. When the appropriate level of anesthesia is confirmed, Group P receives propofol at 25-100ug/kg/min and maintains the BIS at 70-80. Group R receives remimazolam at 1-20ug/kg/min and maintains BIS between 70-80. Both groups apply a conventionally used air heating device, and the operating room temperature is kept at 20 °C. If shivering occurs during surgery, the elapsed time from induction and the shivering grades are recorded.
At the end of the surgery, record total anesthesia time and surgery time, fluid dose, and drug use. After moving to the recovery room, the patient's body temperature, systolic blood pressure, diastolic pressure, heart rate, the incidence of shivering, and the grade of shivering are checked. When shivering occurs, a forced air-warming device is applied first, and if shivering continues, administer meperidine in 5mg increments until the patient is comfortable and record the total dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Problem, Gynecologic Disease, Urinary Tract Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group P
Arm Type
Active Comparator
Arm Description
The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).
Arm Title
Group R
Arm Type
Experimental
Arm Description
The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Fresofol®
Intervention Description
Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Other Intervention Name(s)
Byfavo®
Intervention Description
Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Primary Outcome Measure Information:
Title
The incidence of perioperartive hypothermia
Description
Measure the body temperature on the tympanic membrane three times and enter the highest value.
Time Frame
During surgery
Title
The incidence of perioperartive hypothermia
Description
measure the body temperature three times on the tympanic membrane and enter the highest value.
Time Frame
At PACU (Post Anesthesia Care Unit)
Secondary Outcome Measure Information:
Title
core body temperature
Description
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
Time Frame
Before the induction of anesthesia
Title
core body temperature
Description
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
Time Frame
During surgery
Title
core body temperature
Description
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
Time Frame
At PACU
Title
shivering grades
Description
None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall
Mild (Grade 1): shivering localized to the neck and/or thorax only
Moderate (Grade 2): shivering involved the gross movement of the upper extremities (in addition to neck and thorax)
Severe (Grade 3): shivering involved gross trunk and upper and lower extremities movements.
Time Frame
During surgery
Title
shivering grades
Description
None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall
Mild (Grade 1): shivering localized to the neck and/or thorax only
Moderate (Grade 2): shivering involved the gross movement of the upper extremities (in addition to neck and thorax)
Severe (Grade 3): shivering involved gross trunk and upper and lower extremities movements.
Time Frame
At PACU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
American Society of Anesthesiologists' physical status class (ASA) award class I-III.
Exclusion Criteria:
Patients with fever before surgery
Patients taking antipyretics before surgery
Patients who are chronically using anti-inflammatory drugs
High-risk patients with ASA class IV or higher
Patient who refused sedation
Patients with thyroid dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheolhyeong Lee, M.D.
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonkwag UH
City
Iksan
State/Province
Jeollabukdo
ZIP/Postal Code
54538
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia
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