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

Postoperative nausea and vomiting (PONV) represent significant concerns for patients undergoing surgical procedures, as these symptoms greatly impact their postoperative experience. Among female patients undergoing laparoscopic surgery, the incidence of PONV is estimated to be approximately 45%. Moreover, for those individuals who have not undergone preventive treatment, the risk of experiencing PONV can be as high as 80%.Regrettably, despite ongoing efforts, there is still a lack of a fully effective and comprehensive solution to effectively manage and prevent PONV in these patient populations. The pursuit of an ideal strategy for the prevention and management of PONV remains an active area of research and clinical investigation. This prospective, single-center, randomized, double-blind study was conducted at Gansu Provincial Hospital from June 2021 to March 2022, involving a cohort of 100 subjects aged 18-65 years undergoing non-emergent gynaecological laparoscopic surgery. Prior to anesthesia induction, subjects were intravenously administered either 6.25 mg of promethazine or 1 mL of saline. Postoperatively, all subjects received patient-controlled intravenous analgesia and a continuous infusion of metoclopramide at a rate of 50 mg. The primary outcome measures included assessing the incidence of postoperative nausea and vomiting at 72 h following the surgical procedure. The results of this study show that the overall incidence of postoperative nausea and vomiting within 72 h after operation is significantly different between the two groups before. (P = 0.026, P = 0.012). The incidence and severity of nausea during the early period (the first 6 h postoperatively) was significantly different between groups (P = 0.043, 95%CI(-0.273,-0.019), P = 0.048). A statistically significant difference was found in the incidence and severity within 24 h postoperatively (P = 0.026,95%CI (-0.348,-0.042), 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, 95%CI(-0.164,0.016) P = 0.180). Vomiting incidence and severity were statistically different during the 24 h postoperatively (P = 0.011, 95%CI(-0.342,-0.048),P = 0.004). A significant statistical difference was found in the satisfaction between the two groups during the postoperative observation period (P = 0.002). The administration of preoperative prophylactic promethazine proved to be notably effective in diminishing both the incidence and severity of postoperative nausea and vomiting within the initial 72 h postoperatively. This intervention demonstrated a favorable safety profile, characterized by a minimal occurrence of adverse effects and an absence of serious adverse reactions. Furthermore, the satisfaction levels of patients undergoing this prophylactic approach were observed to be improved. These findings highlight the potential benefits of preoperative prophylactic promethazine in enhancing the postoperative experience for patients, with positive implications for their overall satisfaction with the surgical procedure. Clinical Trials Registration Number: (18/12/2021) ChiCTR2100054495.