Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia

Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia: A Randomized Control Study.

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Disease; Lower Extremity Problem; Urinary Tract Disease
• Intervention / Treatment: Drug: Propofol; Drug: Remimazolam

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabukdo
    • Iksan, Jeollabukdo, Korea, Republic of, 54538
      • Wonkwag UH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group P; The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).	Drug: Propofol; Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.; Other Names: Fresofol®
Experimental: Group R; The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).	Drug: Remimazolam; Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.; Other Names: Byfavo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of perioperartive hypothermia	Measure the body temperature on the tympanic membrane three times and enter the highest value.	During surgery
The incidence of perioperartive hypothermia	measure the body temperature three times on the tympanic membrane and enter the highest value.	At PACU (Post Anesthesia Care Unit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
core body temperature	Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.	Before the induction of anesthesia
core body temperature	Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.	During surgery
core body temperature	Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.	At PACU
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.	During surgery
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.	At PACU

Collaborators and Investigators

• Sponsor: Wonkwang University Hospital
• Investigators: Principal Investigator: Cheolhyeong Lee, M.D., Wonkwang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia; Urologic Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: WonkwangUH12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No