Effect of low-dose ciprofol on postoperative nausea and vomiting following gynecologic day surgery: a randomized controlled trial

低剂量环丙酚对妇科日间手术后恶心呕吐的影响:一项随机对照试验

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Abstract

PURPOSE: Low-dose propofol has a preventive effect on postoperative nausea and vomiting (PONV). Ciprofol is a new short-acting GABA(A) receptor agonist developed in China with a similar chemical structure to propofol, but its effect on PONV is unclear. This study examines whether administration of low-dose ciprofol immediately after the start of surgery reduces the incidence of PONV. PATIENTS AND METHODS: In this study, this study enrolled 75 patients undergoing gynecological ambulatory surgery under general anesthesia, and randomly divided the patients into ciprofol group and normal saline control group. Both groups received remimazolam (6 mg/kg/h) until asleep, then alfentanil (20 μg/kg) and mivacurium (0.2 mg/kg) intravenous, followed by maintenance infusions of remimazolam and alfentanil. Five minutes after the start of the surgery, the ciprofol group was given 2 mL of ciprofol (5 mg) and the control group was given 2 mL of normal saline. The primary outcome measure was the incidence of PONV in the PACU. Secondary outcomes included the incidence of emetic episodes or nausea in the PACU and within 24 h, anesthetic time, wake-up time, and administered doses of remimazolam and alfentanil. Safety outcomes encompassed hypotension, hypertension, bradycardia, and tachycardia. RESULTS: The incidence of PONV in the PACU was significantly lower in the ciprofol group compared to the control group (16.2% vs 52.6%; RR=0.31; 95% CI, 0.14-0.68; ARR=0.364; p = 0.002). The ciprofol group also exhibited a lower incidence of emetic episodes (defined as retching, vomiting, or both) in the PACU (RR=0.27; 95% CI, 0.10-0.75; ARR=0.287; p = 0.005), as well as a lower incidence of nausea (RR=0.31; 95% CI, 0.14-0.68; ARR=0.364; p = 0.002). The frequency of emetic episodes or nausea within 24 h postoperatively was similar between the groups. There were no significant differences between the two groups regarding anesthesia time, wake-up time, remimazolam and alfentanil dosage, or safety indicators (p > 0.05). CONCLUSION: Low-dose ciprofol can effectively prevent PONV in PACU after gynecological day surgery under general anaesthesia remazolam combined with afentanil, but its effect is limited and cannot reduce the incidence of emetic episodes or nausea within 24 h after surgery. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn, identifier ChiCTR2300077247.

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