Abstract | STUDY OBJECTIVE: To identify the maximally effective dolasetron dose (i.e., maximum efficacy with minimum adverse events) for prevention of postoperative nausea and vomiting ( PONV) using the statistical power generated in a pooled patient sample from three large, nearly identical clinical trials. DESIGN: Three randomized, multicenter, placebo-controlled, double-blinded trials. SETTING: Trials 1, 2, and 3 enrolled patients at 10, 25, and 17 hospitals and/or surgical centers, respectively. PATIENTS: INTERVENTIONS: MEASUREMENTS AND MAIN RESULTS: Efficacy endpoints were identical and measured for 24 hours: complete response (no vomiting or rescue medication) and maximum nausea, reported using a 100-mm visual analog scale (VAS). Safety was assessed using adverse event reports, laboratory and electrocardiographic data, and vital signs. All four dolasetron doses produced significant increases in complete response and decreases in maximum VAS nausea compared with placebo (p < 0.01). No increased efficacy was observed with dolasetron doses higher than 12.5 mg. Safety was similar between each dolasetron dose and placebo. CONCLUSION:
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Authors | B K Philip, C H McLeskey, J E Chelly, R McKenzie, A L Kovac, P Diemunsch, D M DuBois |
Journal | Journal of clinical anesthesia
(J Clin Anesth)
Vol. 12
Issue 1
Pg. 1-8
(Feb 2000)
ISSN: 0952-8180 [Print] United States |
PMID | 10773500
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiemetics
- Indoles
- Placebos
- Quinolizines
- dolasetron
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Topics |
- Adult
- Analysis of Variance
- Anesthesia, General
- Antiemetics
(administration & dosage, adverse effects)
- Bradycardia
(chemically induced)
- Chi-Square Distribution
- Double-Blind Method
- Electrocardiography
(drug effects)
- Female
- Follow-Up Studies
- Headache
(chemically induced)
- Humans
- Indoles
(administration & dosage, adverse effects)
- Intraoperative Care
- Logistic Models
- Male
- Placebos
- Postoperative Nausea and Vomiting
(classification, prevention & control)
- Quinolizines
(administration & dosage, adverse effects)
- Safety
- Sex Factors
- Time Factors
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