Postoperative Quality of Recovery After General Anesthesia With Remimazolam

NCT06332157 | Unknown

• 1 other identifier: 2023-ke-715-1
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia Recovery Period

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Remimazolam group

EXPERIMENTAL

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.

Drug: Remimazolam besylate

Propofol group

ACTIVE COMPARATOR

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

Drug: Propofol Injection Emulsion

Interventions

Remimazolam besylate 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.

Remimazolam group

Propofol Injection Emulsion 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.

Propofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA was classified as I-II
• The operative time was less than 180 minutes
• Age ranges from 18 to 65 years
• Informed consent is signed by all study participants

You may not qualify if:

• Pregnant or lactating women
• Patients with Difficult Airways
• History of severe neurological and muscular diseases and mental retardation
• Patients with severe respiratory and circulatory diseases
• Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
• Urea or urea nitrogen ≥1.5×ULN, serum creatinine greater than the upper limit of normal
• Take diazole drugs and/or opioids in one month or nearly three months
• Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc
• Patients who could not monitor the depth of anesthesia for various reasons

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Central Study Contacts

Anshi Wu, doctor

CONTACT

010-85231330; wuanshi88@163.com

Dongjiao An, master

CONTACT

andongjiao@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 27, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-01