Efficacy and Safety of Ramosetron Injection for Nausea and Vomiting in Colorectal-Cancer Patients Undergoing a Laparoscopic Colectomy: A Randomized, Double-Blind, Comparative Study

ABSTRACT

PURPOSE: A laparoscopic colectomy in colorectal-cancer patients is usually associated with a high risk of postoperative nausea and vomiting (PONV). The purpose of this study is to evaluate the efficacy of injection of long-acting 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist for the reduction of PONV in patients with colorectal cancer. METHODS: A total of 48 patients scheduled to undergo a laparoscopic colectomy for colorectal cancer were randomized in a double-blinded fashion. Patients were randomly allocated to 1 of 2 groups and assigned to receive either 0.3 mg of ramosetron intravenously (group A, n = 25) or 2 mL of normal saline (placebo) (group B, n = 22) immediately after the operation. The incidence of PONV, the nausea severity scale score, the visual analogue scale (VAS) score for pain, the total amount of patient-controlled analgesia used, the recovery of bowel function, and morbidities were assessed at 1 hour and at 24, 48, and 72 hours after surgery. RESULTS: The baseline and the operative characteristics were similar between the groups (P > 0.05). The number of cases without PONV (complete response) was higher for group A (ramosetron) than group B (normal saline): 24 hours after surgery, 92.0% (23 of 25) for group A versus 54.5% (12 of 22) for group B; 48 hours after surgery, 92% (23 of 25) for group A versus 81.8% (18 of 22) for group B (both P < 0.05). No serious adverse events occurred. CONCLUSION: Postoperative ramosetron injection is effective for the prevention of PONV after a laparoscopic colectomy in colorectal-cancer patients.