A Randomized, Double-Blinded Comparison of Ondansetron, Droperidol, and Placebo for Prevention of Postoperative Nausea and Vomiting After Supratentorial Craniotomy Jennifer M. Fabling, MB, ChB, FANZCA, Tong J. Gan, MB, FRCA, Habib E. El-Moalem, PhD, David S. Warner, MD, and Cecil O. Borel, MD Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina Nausea or vomiting occurs frequently after craniot- omy. Because of the need for frequent postoperative neurological assessment, an effective antiemetic with minimal sedative side effects is needed. Therefore, we compared ondansetron to droperidol in a randomized, double-blinded, placebo-controlled study. A total of 60 adults requiring elective supratentorial craniotomy re- ceived standardized IV anesthesia with 4 mg of ondan- setron, 0.625 mg of droperidol, or placebo at skin clo- sure. The incidence of postoperative nausea, emesis, pain and sedation scores, and rescue antiemetic use were recorded at 0, 0.5, 1, 4, 8, 12, 24, and 48 h. All groups were demographically similar. Differences ex- isted for cumulative 8, 12, and 24 h incidences of nausea (24 h, P = 0.03) and emesis (24 h, P = 0.04). Within 4 h, when maximal effect could be expected from treatment, 20% of the ondansetron group, 25% of the droperidol group and 50% of the placebo group received rescue antiemetic (P = 0.12). No differences in pain (P = 0.82) or sedation (P = 0.74) scores were detected. Both on- dansetron and droperidol prevent nausea; however, only droperidol reduces emesis after supratentorial craniotomy. The dose of droperidol used was not more sedating than ondansetron. Sustained reduction in nau- sea and emesis over 24 h indicates a preemptive benefit of prophylactic antiemetic in this surgical population. (Anesth Analg 2000;91:358 –61) N ausea or vomiting affects 50% of individuals after craniotomy (1). In addition to causing pa- tient discomfort, protracted postoperative nau- sea and vomiting (PONV) may cause dehydration, acid-based disturbances and electrolyte imbalance. The physical act of vomiting may increase intracranial or cerebral intravascular pressure, jeopardizing hemo- stasis and cerebral perfusion. However, management of PONV may confound patient assessment post- craniotomy if sedative side effects of antiemetics are present. Ondansetron has minimal sedative properties. The efficacy of ondansetron in prevention and treatment of PONV has been demonstrated for many procedures (2). Other work, however, suggests that ondansetron is not superior to droperidol (3–10). In neurosurgical patients there are limited and conflicting reports (11– 14). Ondansetron was effective in two cases of head injury (12) and when compared to placebo prophy- laxis in patients undergoing infratentorial surgery (14). However, prophylactic ondansetron was of no benefit when compared to placebo, in pediatric (11), and with metoclopramide in adult craniotomy pa- tients (13). Ondansetron has not been compared with droperidol in patients undergoing craniotomy. In this study, we compared the efficacy and side-effect pro- files of ondansetron, droperidol, and placebo for pre- vention of PONV in patients undergoing supratento- rial craniotomy. Methods We designed this study as a randomized, double- blinded, placebo-controlled, prospective trial. With in- stitutional review board approval, 60 patients ages 18 –75 yr scheduled for elective supratentorial craniot- omy for mass lesion gave written, informed consent for participation in this study. Exclusion criteria were ASA physical status IV or V, antiemetic use pre- or intraoperatively, allergy to ondansetron or droperidol, pregnancy, breast feeding, morbid obesity, mental re- tardation, or psychiatric illness. For women of child- bearing potential, a negative serum -hCG test was confirmed before enrollment. Accepted for publication April 26, 2000. Address correspondence to Cecil Borel, MD, Department of An- esthesiology, DUMC Box 3094, Duke University, Durham, NC 27710. Address e-mail to borel001@mc.duke.edu. ©2000 by the International Anesthesia Research Society 358 Anesth Analg 2000;91:358–61 0003-2999/00