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

NCT ID: NCT05574257

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-09-02

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.

Conditions

Lower Extremity Problem; Gynecologic Disease; Urinary Tract Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group P

The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.

Group R

The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Fresofol®; Byfavo®

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wonkwang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheol Lee,MD,PhD,

Professor of Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheolhyeong Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wonkwang University Hospital

Locations

Wonkwag UH

Iksan, Jeollabukdo, South Korea

Countries

South Korea

Other Identifiers

WonkwangUH12

Identifier Type: -

Identifier Source: org_study_id