Preoperative Oral Betahistine for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized, Double-Blind, Placebo-Controlled Trial

Background Postoperative nausea and vomiting (PONV) are a common complication after laparoscopic cholecystectomy, with incidence rates exceeding 50% in high-risk patients without prophylaxis. Betahistine, a histamine analogue with vestibular-modulating properties, has shown promise in reducing PONV in limited prior studies. This trial aimed to evaluate the efficacy and safety of preoperative oral betahistine as monotherapy for PONV prevention. Methods In this prospective, randomized, double-blind, placebo-controlled trial conducted from January 2019 to December 2021, 228 patients (ASA I–II, aged 20–60 years) scheduled for elective laparoscopic cholecystectomy were randomized to receive a single oral dose of betahistine 8 mg or identical placebo 2 hours preoperatively. No other prophylactic antiemetics were administered. The primary outcome was the incidence of PONV over 48 hours postoperatively. Secondary outcomes included nausea severity (verbal rating scale 0–10), vomiting episodes, rescue antiemetic requirements (time-to-event analyzed via Kaplan–Meier), pain scores, opioid consumption, time to oral intake, hospital discharge, patient satisfaction, and adverse events. Analysis was by intention-to-treat. Results PONV occurred in 36/111 patients (32.4%) in the betahistine group versus 63/111 (56.8%) in the placebo group (P < 0.001; relative risk reduction 42.9%, 95% CI 27.1–56.3%). Nausea severity was significantly lower in the betahistine group at most time points (P < 0.05). Rescue antiemetic use was reduced (25.2% vs. 45.9%; P = 0.002), with longer time to first dose (median 7.8 vs. 4.1 hours; log-rank P = 0.008). Betahistine accelerated oral intake (median 6.2 vs. 7.9 hours; P = 0.028), with a trend toward earlier hospital discharge (43.1 vs. 48.6 hours; P = 0.056) and higher patient satisfaction (8.4 ± 1.6 vs. 6.9 ± 2.1; P < 0.001). No serious adverse events occurred; mild adverse events (primarily headache and gastric upset) were slightly more frequent in the betahistine group (7.2% vs. 2.7%; P = 0.121). Conclusion Preoperative betahistine 8 mg effectively and safely reduces PONV incidence and severity after laparoscopic cholecystectomy, with benefits in early recovery and patient satisfaction. It represents a valuable prophylactic option warranting integration into clinical practice.