Double-blind, placebo-controlled, dose-ranging study of ramosetron for the prevention of nausea and vomiting after thyroidectomy.
BACKGROUND
Patients receiving general anesthesia during thyroidectomy have a high risk for postoperative nausea and vomiting.


OBJECTIVE
This prospective, randomized, double-blind, placebo-controlled, dose-ranging study was undertaken to assess the efficacy and safety of ramosetron, a selective 5-hydroxytryptamine type 3-receptor antagonist, in preventing nausea and vomiting after thyroidectomy.


METHODS
Standard general anesthetic technique and postoperative analgesia were employed. Patients undergoing thyroidectomy were randomized to receive IV ramosetron 0.15, 0.3, or 0.6 mg or placebo at completion of the procedure. During the first 48 hours after anesthesia, episodes of emesis and adverse events were assessed by nursing staff who were blinded to patients' treatment assignment.


RESULTS
Eighty patients (22 men, 58 women; age range, 28-63 years; weight range, 37-91 kg) were enrolled in the study. There were no differences in demographic characteristics between treatment groups. The numbers of patients who were emesis free (no nausea, retching, or vomiting) 0 to 24 hours after anesthesia were 10 of 20 (50%) with ramosetron 0.15 mg, 17 of 20 (85%) with ramosetron 0.3 mg, 18 of 20 (90%) with ramosetron 0.6 mg, and 8 of 20 (40%) with placebo. The corresponding numbers 24 to 48 hours after anesthesia were 11 of 20 (55%), 18 of 20 (90%), 18 of 20 (90%), and 9 of 20 (45%). At both time points, only the values for ramosetron 0.3 and 0.6 mg were statistically significant versus placebo (P < or = 0.001). No clinically serious adverse events were observed in any group.


CONCLUSIONS
In this population of patients receiving general anesthesia while undergoing thyroidectomy, ramosetron 0.3 mg was effective in preventing postoperative nausea and vomiting 0 to 48 hours after anesthesia. Increasing the dose to 0.6 mg provided no demonstrable benefit.
Fujii
Yoshitaka
Y
Department of Anesthesiology, Toride Kyodo General Hospital, Toride City, Ibaraki, Japan. yfujii@igaku.md.tsukuba.ac.jp
Tanaka
Hiroyoshi
H
D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D020250:Postoperative Nausea and Vomiting / Q000188:drug therapy* / Q000209:etiology; D013965:Thyroidectomy / Q000009:adverse effects; D016896:Treatment Outcome
D000932:Antiemetics; D001562:Benzimidazoles; C071315:ramosetron