Abstract | STUDY OBJECTIVE: DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: 32 hospitals. PATIENTS: INTERVENTIONS: 25, 50, 100, or 200 mg oral doses of dolasetron mesylate or placebo were administered 1 to 2 hours before induction of anesthesia. Efficacy was assessed for 24 hours postrecovery by measuring complete response (no emetic episodes, no rescue medication), total response (complete response with no nausea), time to first emetic episode or rescue, and patient visual analog scale evaluations of nausea severity and satisfaction with antiemetic therapy. MEASUREMENTS AND MAIN RESULTS: Complete response rates for the 50, 100, and 200 mg dose groups were statistically greater than placebo (p < or = 0.018). Likewise, total response rates were statistically greater in the 50, 100, and 200 mg dose groups than in the placebo group (p = 0.012). Percentage of patients with no nausea and patient satisfaction scores were significantly higher for each dolasetron dose group than placebo (p < or = 0.047 and p < or = 0.004, respectively). Efficacy peaked at the 50 mg dose. The incidence of adverse events was similar in the placebo (30.1%) and dolasetron groups (29.4%). Headache was the most frequent treatment-related adverse event, with 2% to 5% incidence across groups. Incidence of adverse events did not increase with increasing dolasetron doses. Dose-related decreases in blood pressure at acute time points were not clinically significant. CONCLUSION:
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Authors | P Diemunsch, K Korttila, J Leeser, J H Helmers, B Wilkey, S Navé, A J Radke, W F Hahne, R A Brown |
Journal | Journal of clinical anesthesia
(J Clin Anesth)
Vol. 10
Issue 2
Pg. 145-52
(Mar 1998)
ISSN: 0952-8180 [Print] United States |
PMID | 9524901
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiemetics
- Indoles
- Quinolizines
- dolasetron
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Topics |
- Adolescent
- Adult
- Anesthesia, General
- Antiemetics
(adverse effects, therapeutic use)
- Blood Pressure
(drug effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Gynecologic Surgical Procedures
- Humans
- Indoles
(adverse effects, therapeutic use)
- Middle Aged
- Nausea
(prevention & control)
- Postoperative Complications
(prevention & control)
- Quinolizines
(adverse effects, therapeutic use)
- Vomiting
(prevention & control)
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