Promethazine for nausea and vomiting prevention after gynaecological laparoscopic surgery：a randomized controlled trial

Abstract Background: Postoperative nausea and vomiting (PONV) are the postoperative problem that patients undergoing surgery do not want to experience. The incidence of PONV in female patients undergoing laparoscopic surgery is about 40%, and the risk of PONV is as high as 80% in those patients who have not received preventive treatment. At present still did not have the consummation effective solution. Methods: This prospective, single-centre, two-armed, randomised, double-blind, pilot study was conducted in Gansu Provincial Hospital from June 2021 to March 2022 and included 100 subjects, aged 18–65 years, who underwent nonemergent gynaecological laparoscopic surgery. Before anaesthesia induction, 6.25-mg promethazine or 1-mL saline was intravenously administered. All subjects received postoperative patient-controlled intravenous analgesia and continuous metoclopramide infusion at 50 mg. The primary outcome was the incidence and severity of postoperative nausea and vomiting at 6 h, 24 h, 48 h, and 72 h postoperatively. Results:The incidence and severity of nausea during the early period (the first 6 h postoperatively) was significantly different between groups (P = 0.043, P = 0.048). A statistically significant difference was found in the incidence and severity within 24 h postoperatively (P = 0.026, P = 0.003). Vomiting incidence and severity were lower than in the control group at the 6 h postoperatively but without statistical difference between the two groups (P = 0.166, P = 0.180). Vomiting incidence and severity were statistically different during the 24 h postoperatively (P = 0.011, P = 0.004). A significant statistical difference was found in the satisfaction between the two groups during the postoperative observation period (P = 0.002). Conclusion:Preoperative prophylactic promethazine significantly reduced the incidence and severity of postoperative nausea and vomiting within 24 h postoperatively, with few adverse effects and no serious adverse reactions. And the satisfaction of patients is improved. Clinical Trials Registration Number:（18/12/2021）ChiCTR2100054495