Postoperative Quality of Recovery After General Anesthesia With Remimazolam

NCT ID: NCT06332157

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-31

Brief Summary

126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome.

Detailed Description

This study was a randomized, single-blind, single-center, positive drug controlled, non-inferiority trial. According to the inclusion and exclusion criteria, 126 patients undergoing general anesthesia for elective non-cardiac surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. After the patient lost consciousness, routine analgesia and muscle relaxants were given, followed by tracheal intubation and mechanical ventilation. During the anesthesia maintenance phase, vital signs and depth of anesthesia were continuously monitored, sedatives and analgesics were continuously pumped, and muscle relaxants were added intermittently as needed. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome.

Conditions

Anesthesia Recovery Period

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam group

Anesthesia was induced by pump injection of remimazolam besylate at a rate of 6mg/min. Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump.

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

In Remimazolam group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min and maintained with 1.0-2.0mg/min until the end of surgery.

Propofol group

Anesthesia was induced with propofol injection 2mg/kg intravenously. Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol injection.

Group Type: ACTIVE_COMPARATOR

Propofol Injection Emulsion

Intervention Type: DRUG

In Propofol group, anesthesia was induced with propofol injection emulsion at a rate of 2mg/kg and maintained with 6-8mg/kg/h until the end of surgery.

Interventions

Remimazolam besylate

In Remimazolam group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min and maintained with 1.0-2.0mg/min until the end of surgery.

Intervention Type: DRUG

Propofol Injection Emulsion

In Propofol group, anesthesia was induced with propofol injection emulsion at a rate of 2mg/kg and maintained with 6-8mg/kg/h until the end of surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ASA was classified as I-II

2. The operative time was less than 180 minutes

3. Age ranges from 18 to 65 years

4. Informed consent is signed by all study participants

Exclusion Criteria

1. Pregnant or lactating women

2. Patients with Difficult Airways

3. History of severe neurological and muscular diseases and mental retardation

4. Patients with severe respiratory and circulatory diseases

5. Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range

6. Urea or urea nitrogen ≥1.5×ULN, serum creatinine greater than the upper limit of normal

7. Take diazole drugs and/or opioids in one month or nearly three months

8. Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc

9. Patients who could not monitor the depth of anesthesia for various reasons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Anshi Wu, doctor

Role: CONTACT

wuanshi88@163.com

010-85231330

Dongjiao An, master

Role: CONTACT

andongjiao@aliyun.com

Other Identifiers

2023-ke-715-1

Identifier Type: -

Identifier Source: org_study_id