Volume 36, Issue 4 (12-2025)
Studies in Medical Sciences 2025, 36(4): 72-78 |
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Hassani E, Neisari R, Mahoori A. Preoperative Oral Betahistine for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized, Double-Blind, Placebo-Controlled Trial. Studies in Medical Sciences 2025; 36 (4) :72-78
URL: http://umj.umsu.ac.ir/article-1-6540-en.html
URL: http://umj.umsu.ac.ir/article-1-6540-en.html
Department of Anesthesiology, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran , dr.neisary@gmail.com
Abstract: (201 Views)
Background: PONV affects more than 50% of high-risk patients undergoing laparoscopic cholecystectomy without prophylaxis. Betahistine, a histamine analog with vestibular-modulating properties, has shown promise in reducing PONV in limited prior studies. This trial evaluated the efficacy and safety of preoperative oral betahistine as monotherapy for PONV prevention.
Methods: In this prospective, randomized, double-blind, placebo-controlled trial (January 2019–December 2021), 228 patients (ASA I–II, aged 20–60 years) undergoing elective laparoscopic cholecystectomy were randomized to betahistine 8 mg or identical placebo orally 2 hours preoperatively, with no other prophylactic antiemetics. The primary outcome was PONV incidence over 48 hours. Secondary outcomes included nausea severity (VRS 0–10), vomiting episodes, rescue antiemetic use (Kaplan–Meier analysis), pain scores, opioid consumption, time to oral intake, hospital discharge, patient satisfaction, and adverse events. Analysis was 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 47.4%; 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 lower (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 discharge (43.1 vs. 48.6 hours; p = 0.056) and higher satisfaction (8.4 ± 1.6 vs. 6.9 ± 2.1; p < 0.001). Mild adverse events (headache and gastric upset) were slightly more frequent with betahistine (7.2% vs. 2.7%; p = 0.121); no serious adverse events occurred.
Conclusion: Preoperative betahistine 8 mg effectively and safely reduces PONV incidence and severity after laparoscopic cholecystectomy, with benefits in early recovery and patient satisfaction, representing a valuable prophylactic option warranting clinical integration.
Keywords: Antiemetic prophylaxis, Betahistine, Laparoscopic cholecystectomy, Postoperative nausea and vomiting, Randomized controlled trial
Type of Study: Research |
Subject:
Anesthesia
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