Postoperative Quality of Recovery After General Anesthesia With Remimazolam

Anesthesia Recovery Period Clinical Trial

Official title:

Postoperative Quality of Recovery After Patients' Undergoing General Anesthesia With Remimazolam Compared to Propofol, A Randomized Non-inferiority Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332157
• Other study ID #: 2023-ke-715-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Beijing Chao Yang Hospital
• Contact: Anshi Wu, doctor
• Phone: 010-85231330
• Email: wuanshi88[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Recovery Period

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	15-item quality of recovery scale	Patient-measured scales. It was composed of 15 items of five dimensions: physical well-being, physical independence, emotional state, psychological support, and pain. The scale is scored from 0 to 150. Higher scores indicate better quality of recovery.	24 hours after surgery