Adult Studies: Adult surgical patients who received ondansetron immediately before the induction of general balanced anesthesia (barbiturate: thiopental, methohexital, or thiamylal; opioid: alfentanil or fentanyl; nitrous oxide; neuromuscular blockade: succinylcholine/curare and/or vecuronium or atracurium; and supplemental isoflurane) were evaluated in two double-blind US studies involving 554 patients. ZOFRAN Injection (4 mg) I.V. given over 2 to 5 minutes was significantly more effective than placebo. The results of these studies are summarized in Table 8.

Table 8. Prevention of Postoperative Nausea and Vomiting in Adult Patients

The study populations in Table 8 consisted mainly of females undergoing laparoscopic procedures.

In a placebo-controlled study conducted in 468 males undergoing outpatient procedures, a single 4-mg I.V. ondansetron dose prevented postoperative vomiting over a 24-hour study period in 79% of males receiving drug compared to 63% of males receiving placebo (P < 0.001).

Two other placebo-controlled studies were conducted in 2,792 patients undergoing major abdominal or gynecological surgeries to evaluate a single 4-mg or 8-mg I.V. ondansetron dose for prevention of postoperative nausea and vomiting over a 24-hour study period. At the 4-mg dosage, 59% of patients receiving ondansetron versus 45% receiving placebo in the first study (P < 0.001) and 41% of patients receiving ondansetron versus 30% receiving placebo in the second study (P=0.001) experienced no emetic episodes. No additional benefit was observed in patients who received I.V. ondansetron 8 mg compared to patients who received I.V. ondansetron 4 mg.

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