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

Condition(s) studied

Investigational drug(s) / intervention(s)

Propofol: 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

Ciprofol: 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

Remimazolam: 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

Study 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

Primary outcome measure(s)

• Incidence of postoperative nausea and vomiting within 24 hours after surgery — 24 hours after surgery
  The proportion of patients who experience nausea and/or vomiting within the first 24 hours after surgery. Postoperative nausea and vomiting (PONV) is defined as nausea and/or vomiting occurring within 24 hours postoperatively. Severity will be graded according to World Health Organization (WHO) criteria: Grade I, no nausea or retching; Grade II, mild nausea with abdominal discomfort but no vomiting; Grade III, nausea with retching but no expulsion of gastric contents; Grade IV, severe vomiting with expulsion of gastric contents requiring pharmacological intervention. Overall PONV incidence = (Grade II + Grade III + Grade IV cases) / total cases × 100%.

Trial sites (1)

Other trials for the same condition