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.
Age 18-80 years, either sex American Society of Anesthesiologists (ASA) physical status classification I-III Scheduled for elective laparoscopic cholecystectomy under general anesthesia Able to understand the study protocol and provide written informed consent Not concurrently enrolled in other clinical studies
Known hypersensitivity to any anesthetic agent used in the study Severe cardiac, pulmonary, hepatic, or renal dysfunction Active systemic infectious disease Psychiatric disorder or use of sedative agents within the preceding two weeks Refusal to participate
Parallel
Propofol
DrugDrug: 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
DrugDrug: 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
DrugDrug: 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
Incidence of postoperative nausea and vomiting within 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%.
Incidence of Nausea Within 24 Hours After Surgery
The proportion of patients who experience nausea (a subjective unpleasant sensation associated with the urge to vomit) within the first 24 hours after surgery.
Incidence of Vomiting Within 24 Hours After Surgery
The proportion of patients who experience vomiting (expulsion of gastric contents) within the first 24 hours after surgery.
Number of Nausea Episodes Within 24 Hours After Surgery
The total number of discrete nausea episodes experienced by each patient during the first 24 hours after surgery. An episode is defined as a distinct period of nausea separated from other episodes by at least 5 minutes of no nausea.
Number of Vomiting Episodes Within 24 Hours After Surgery
The total number of discrete vomiting episodes (forceful expulsion of gastric contents) experienced by each patient during the first 24 hours after surgery. An episode is defined as a distinct vomiting event separated from other vomiting events by at least 5 minutes.
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