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Online ISSN 1827-1596
Jin S. CHO 1, 2, Eun J. KIM 1, 2, Jae H. LEE 1, 2, So Y. KIM 1, 2, Jeong M. KIM 1, 2, Jung I. BYUN 1, Eun J. NAM 3, Bon N. KOO 1, 2
1 Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, South Korea; 2 Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea; 3 Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Korea
BACKGROUND: Patients undergoing laparoscopic gynecological surgery are at high risk of postoperative nausea and vomiting (PONV). We compared the antiemetic efficacy of ondansetron plus betahistine with that of ondansetron alone in this patient population.
METHODS: In this randomized, double-blinded study, 168 patients were randomly allocated to receive placebo (O group) or betahistine 18 mg (OB group) orally 3 hours before surgery and 24 hours thereafter. In both groups, ondansetron 4 mg was administered at the end of surgery and 8 mg were added to an intravenous patient-controlled analgesia (IV-PCA) fentanyl solution. The primary outcome was complete response (no PONV and no rescue antiemetics) during the first 48 hours after surgery. The severity of nausea, pain score, and adverse events were assessed.
RESULTS: The incidence of complete response was significantly higher in OB group than in O group (69% vs. 46%, P=0.004). The severity of nausea was lower in OB group than in O group during 30 minutes to 6 hours and 6 to 24 hours after surgery (P=0.001 and P<0.001). Pain score was similar between the groups. The incidence of dizziness was lower in OB group than in O group (13% vs. 40%, P < 0.001). Six patients (7%) in OB group and 15 patients (18%) in O group required early IV-PCA discontinuation, primarily because of PONV and/or dizziness (P=0.038).
CONCLUSIONS: Compared to ondansetron alone, ondansetron plus betahistine was more effective to prevent PONV and dizziness in high-risk patients undergoing laparoscopic gynecological surgery.