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

Gynecologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574257
• Other study ID #: WonkwangUH12
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 2, 2022

Study information

• Verified date: October 2022
• Source: Wonkwang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Disease
• Hypothermia
• Lower Extremity Problem
• Urinary Tract Disease
• Urologic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Wonkwag UH	Iksan	Jeollabukdo

Sponsors (1)

Lead Sponsor	Collaborator
Wonkwang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of perioperartive hypothermia	Measure the body temperature on the tympanic membrane three times and enter the highest value.	During surgery
Primary	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	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
Secondary	core body temperature	Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.	During surgery
Secondary	core body temperature	Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.	At PACU
Secondary	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
Secondary	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