RecruitingPhase 4NCT07758803

A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy

A Prospective, Randomized, Controlled, Single-Blind Clinical Trial Comparing the Effects of Propofol, Ciprofol, and Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy


Sponsor

Xi'an Aerospace General Hospital

Enrollment

114 participants

Start Date

Aug 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to compare three sedative medications used during general anesthesia for gallbladder removal surgery (laparoscopic cholecystectomy) and their effects on nausea and vomiting after surgery. Background Nausea and vomiting after surgery (postoperative nausea and vomiting, PONV) is a common problem, affecting up to 75% of patients undergoing gallbladder surgery. It can cause discomfort, delay recovery, and lead to other complications. Three medications are commonly used to start and maintain anesthesia: propofol, ciprofol, and remimazolam. This study aims to find out which one is associated with the least nausea and vomiting. Study Design This is a prospective, randomized, controlled, single-blind clinical trial. A total of 114 adult patients scheduled for elective laparoscopic cholecystectomy at Xi'an Aerospace Hospital will be randomly assigned to one of three groups (38 patients each): Propofol group Ciprofol group Remimazolam group All patients will receive the same anti-nausea prevention and pain control after surgery, regardless of their group. Primary Outcome (Main Measure) The percentage of patients who experience any nausea and/or vomiting within the first 24 hours after surgery. Secondary Outcomes (Other Measures) Percentage of patients who experience vomiting within 24 hours after surgery Percentage of patients who experience nausea within 24 hours after surgery Number of nausea, vomiting, and combined PONV episodes within 24 hours Pain level measured on a 0-10 visual analog scale (VAS) at 0, 6, 12, and 24 hours after surgery (0 = no pain, 10 = worst pain imaginable) Highest pain score reported within the first 24 hours after surgery Significance The results will help doctors choose the best sedative medication to reduce nausea and vomiting after gallbladder surgery, especially for patients who are at higher risk, such as women.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ciprofol, a drug called Propofol, and others for people with cholelithiasis and postoperative nausea and vomiting. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropofol

Drug: Propofol (Yangtze River Pharmaceutical Group, Taizhou, Jiangsu, China) Induction: 2 mg/kg intravenously over ≥ 30 seconds Maintenance: 4-12 mg/kg/h by continuous intravenous infusion, titrated to maintain BIS between 40 and 60

DRUGCiprofol

Drug: Ciprofol (HSK3486; Haisco Pharmaceutical Group, Shenyang, Liaoning, China) Induction: 0.4 mg/kg intravenously over ≥ 30 seconds Maintenance: 0.8-1.2 mg/kg/h by continuous intravenous infusion, titrated to maintain BIS between 40 and 60

DRUGRemimazolam

Drug: Remimazolam besylate (Yichang Humanwell Pharmaceutical, Yichang, Hubei, China) Induction: 0.3 mg/kg intravenously over ≥ 1 minute Maintenance: 0.3-1.0 mg/kg/h by continuous intravenous infusion, titrated to maintain BIS between 40 and 60


Locations(1)

Xi'an Aerospace Hospital

Xi'an, Shaanxi, China

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NCT07758803


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