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Efficacy of Single-dose and 2-dose Intravenous Administration of Ramosetron in Preventing Postoperative Nausea and Vomiting After Laparoscopic Gynecologic Operation

A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial

Lee, Banghyun MD, PhD*; Kim, Kidong MD, PhD; Suh, Dong Hoon MD; Shin, Hyun-Jung MD; No, Jae Hong MD, PhD; Lee, Jung Ryeol MD, PhD; Jee, Byung Chul MD, PhD†,§; Hwang, Jung Won MD, PhD‡,§; Do, Sang Hwan MD, PhD‡,§; Kim, Yong Beom MD, PhD†,§

Surgical Laparoscopy Endoscopy & Percutaneous Techniques: June 2017 - Volume 27 - Issue 3 - p 183–188
doi: 10.1097/SLE.0000000000000399
Original Articles

This randomized trial investigated whether a 2-dose administration of intravenous ramosetron (5-hydroxytryptamine type 3 receptor antagonist) is more effective than a single-dose administration in preventing postoperative nausea and vomiting (PONV) in 89 patients who were scheduled to undergo laparoscopic operation for benign gynecologic diseases and to receive intravenous patient-controlled analgesia for relief of postoperative pain. After assignment at a ratio of 1:1, intravenous ramosetron (0.3 mg) was initially administered at the end of skin closure in all patients. Thereafter, ramosetron (0.3 mg) and placebo were administered to the study and control groups, respectively, at 4 hours after the operation. The baseline and operative characteristics were similar between the groups. The incidence of PONV during the 24-hour period after operation which was assessed as the primary endpoint did not differ between the groups. No serious adverse events occurred in either group. A 2-dose administration of intravenous ramosetron may not be superior to a single-dose administration in preventing PONV in patients undergoing laparoscopic operation for benign gynecologic diseases.

*Department of Obstetrics and Gynecology, Hallym University Kangdong Sacred Heart Hospital

§School of Medicine, Seoul National University, Seoul

Departments of Obstetrics and Gynecology

Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Gyeonggi-Do, Republic of Korea

B. L. and K. K. contributed equally to this work and are co-first authors.

Supported by Astellas Pharma Korea Inc. The sponsors were not involved in study design; collection, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The authors declare no conflicts of interest.

Reprints: Yong Beom Kim, MD, PhD, Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, 82, Gumi-ro 173 beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (e-mail:

Received July 16, 2016

Accepted March 16, 2017

Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.