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CLINICAL TRIAL
ENGLISH ABSTRACT
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
[The efficacy of droperidol, metoclopramide, propofol, and ondansetron for the prevention of nausea and vomiting following middle ear surgery].
OBJECTIVES: The efficacy and reliability of prophylactic antiemetic therapy with low dose propofol, droperidol, metoclopramide, and ondansetron were evaluated in a randomized, double-blind, and prospective design.
PATIENTS AND METHODS: A total of 101 ASA I-II patients (34 females, 67 males; age range 16 to 53 years) undergoing middle ear surgery for chronic otitis media or its sequelae were randomly assigned to receive prophylactic antiemetic therapy with propofol (n=21, 0.5 mg/kg), droperidol (n=19, 20 mg/kg), metoclopramide (n=23, 0.2 mg/kg), ondansetron (n=21, 4 mg), and placebo (n=20, 0.9% NaCl). All drugs were administered intravenously five minutes before extubation.
RESULTS: In the early postoperative period (0 to 3 hours), the percentages of patients free from nausea and vomiting were 100% with droperidol, 71.4% with ondansetron and propofol, 52.1% with metoclopramide, and 35% with placebo. Ondansetron (90.4%) was found the most effective to prevent and control nausea and vomiting during the postoperative 3 to 24 hours, followed by droperidol (84.2%), propofol (57.1%), metoclopramide (47.8%), and placebo (40%). Compared with controls, the number of patients without nausea and vomiting was significantly greater in each treatment group but metoclopramide (p<0.05). No significant differences were detected with respect to adverse effects.
CONCLUSION: Droperidol and ondansetron seem to exert the highest efficacy to prevent nausea and vomiting during the postoperative 0 to 3 hours and 3 to 24 hours, respectively.
PATIENTS AND METHODS: A total of 101 ASA I-II patients (34 females, 67 males; age range 16 to 53 years) undergoing middle ear surgery for chronic otitis media or its sequelae were randomly assigned to receive prophylactic antiemetic therapy with propofol (n=21, 0.5 mg/kg), droperidol (n=19, 20 mg/kg), metoclopramide (n=23, 0.2 mg/kg), ondansetron (n=21, 4 mg), and placebo (n=20, 0.9% NaCl). All drugs were administered intravenously five minutes before extubation.
RESULTS: In the early postoperative period (0 to 3 hours), the percentages of patients free from nausea and vomiting were 100% with droperidol, 71.4% with ondansetron and propofol, 52.1% with metoclopramide, and 35% with placebo. Ondansetron (90.4%) was found the most effective to prevent and control nausea and vomiting during the postoperative 3 to 24 hours, followed by droperidol (84.2%), propofol (57.1%), metoclopramide (47.8%), and placebo (40%). Compared with controls, the number of patients without nausea and vomiting was significantly greater in each treatment group but metoclopramide (p<0.05). No significant differences were detected with respect to adverse effects.
CONCLUSION: Droperidol and ondansetron seem to exert the highest efficacy to prevent nausea and vomiting during the postoperative 0 to 3 hours and 3 to 24 hours, respectively.
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