STUDY OBJECTIVES: To investigate the hypothesis that the combination of ondansetron and droperidol would be more effective than droperidol alone in reducing nausea and vomiting. DESIGN: Randomized, doubleblind study. SETTING: Magee-Womens Hospital, Pittsburgh, Pennsylvania. PATIENTS: 160 healthy, ASA physical status I and II, female patients scheduled for total abdominal hysterectomy. INTERVENTIONS: After induction of anesthesia with propofol, Group 1 received intravenous (i.v.) droperidol 1.25 mg plus i.v. ondansetron 4 mg. Group 2 received i.v. droperidol plus i.v. saline. MEASUREMENTS AND MAIN RESULTS: The complete response (no emesis, no rescue) for Group 1 was 36 of 80 patients (45%) versus 30 of 80 patients (38%) in Group 2 (p = 0.21). In Group 1, 42 of 80 patients (53%) required rescue antiemetic as compared with 44 of 80 patients (55%) in Group 2 (p = 0.43). There were 72 total rescues in Group 1 versus 73 in Group 2, (p = 0.24). Mean time until first rescue was 578 +/- 429 minutes in Group 1 and 418 +/- 354 minutes in Group 2, (p = 0.03). In Group 1, 81 % (34/42) were rescued for nausea only versus 90% (39/44) of Group 2 (p = 0.16). In Group 1, 21% of patients (17/80) had at least one emetic episode versus 34% (27/80) of Group 2 patients (p = 0.05). There were 31 emetic episodes in Group 1 versus 72 episodes in Group 2. (p = 0.02). Mean time to the first emetic episode was 699 +/- 403 minutes in Group 1 and 616 +/- 376 minutes in Group 2, (p = 0.23). CONCLUSION: For patients undergoing total abdominal hysterectomies, the addition of ondansetron to droperidol increases the time until first rescue and reduces the number of emetic episodes, as well as the percentage of patients, having at least one emetic episode.
RCT Entities:
STUDY OBJECTIVES: To investigate the hypothesis that the combination of ondansetron and droperidol would be more effective than droperidol alone in reducing nausea and vomiting. DESIGN: Randomized, doubleblind study. SETTING: Magee-Womens Hospital, Pittsburgh, Pennsylvania. PATIENTS: 160 healthy, ASA physical status I and II, female patients scheduled for total abdominal hysterectomy. INTERVENTIONS: After induction of anesthesia with propofol, Group 1 received intravenous (i.v.) droperidol 1.25 mg plus i.v. ondansetron 4 mg. Group 2 received i.v. droperidol plus i.v. saline. MEASUREMENTS AND MAIN RESULTS: The complete response (no emesis, no rescue) for Group 1 was 36 of 80 patients (45%) versus 30 of 80 patients (38%) in Group 2 (p = 0.21). In Group 1, 42 of 80 patients (53%) required rescue antiemetic as compared with 44 of 80 patients (55%) in Group 2 (p = 0.43). There were 72 total rescues in Group 1 versus 73 in Group 2, (p = 0.24). Mean time until first rescue was 578 +/- 429 minutes in Group 1 and 418 +/- 354 minutes in Group 2, (p = 0.03). In Group 1, 81 % (34/42) were rescued for nausea only versus 90% (39/44) of Group 2 (p = 0.16). In Group 1, 21% of patients (17/80) had at least one emetic episode versus 34% (27/80) of Group 2 patients (p = 0.05). There were 31 emetic episodes in Group 1 versus 72 episodes in Group 2. (p = 0.02). Mean time to the first emetic episode was 699 +/- 403 minutes in Group 1 and 616 +/- 376 minutes in Group 2, (p = 0.23). CONCLUSION: For patients undergoing total abdominal hysterectomies, the addition of ondansetron to droperidol increases the time until first rescue and reduces the number of emetic episodes, as well as the percentage of patients, having at least one emetic episode.
Authors: Stephanie Weibel; Gerta Rücker; Leopold Hj Eberhart; Nathan L Pace; Hannah M Hartl; Olivia L Jordan; Debora Mayer; Manuel Riemer; Maximilian S Schaefer; Diana Raj; Insa Backhaus; Antonia Helf; Tobias Schlesinger; Peter Kienbaum; Peter Kranke Journal: Cochrane Database Syst Rev Date: 2020-10-19