A double-blind, parallel-group, placebo-controlled, dose-ranging, multicenter study of intravenous granisetron in the treatment of postoperative nausea and vomiting in patients undergoing surgery with general anesthesia.

STUDY OBJECTIVE

To compare the effectiveness of granisetron with placebo in the treatment of established postoperative nausea and vomiting (PONV).

DESIGN

Randomized, placebo-controlled study.

SETTING

34 hospitals in Europe, Scandinavia, and South Africa.

PATIENTS

519 ASA physical status I, II, and III patients who developed PONV within 4 hours of the end of surgery performed with general anesthesia.

INTERVENTIONS

Patients received a single intravenous dose of granisetron 0.1 mg, 1 mg, or 3 mg, or placebo when symptoms of nausea or vomiting were experienced. Additional rescue medication could be given at the investigator's discretion if nausea and vomiting were not controlled.

MEASUREMENTS AND MAIN RESULTS

At all doses investigated, granisetron was significantly more effective (p < or = 0.001) than placebo in controlling vomiting: 38%, 46%, and 49% of patients receiving granisetron, 0.1 mg, 1.0 mg, and 3.0 mg, respectively, experienced no vomiting in the first 24 hours following drug administration, compared with 20% receiving placebo. There was a statistically significant linear relationship between vomiting control and granisetron dose (p < 0.001). Survival distributions of time to resolution of vomiting confirmed the statistically significant difference between patients receiving granisetron and those receiving placebo. Granisetron was well tolerated: the most common adverse experiences were pain, constipation, anemia, and headache, and the incidence of adverse experiences was not statistically significantly higher in any of the granisetron groups than in the placebo group.

CONCLUSION

Granisetron was significantly more effective than placebo in all groups. Further studies in specific subgroups may be warranted.