Clinical trial NCT06332157: Postoperative Quality of Recovery After General Anesthesia With Remimazolam
Official title: Postoperative Quality of Recovery After Patients' Undergoing General Anesthesia With Remimazolam Compared to Propofol, A Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia Recovery Period
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 15-item quality of recovery scale
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
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