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BMJ. 2006 Aug 12;333(7563):324. Epub 2006 Jul 21.

Prevention of postoperative nausea and vomiting by metoclopramide combined with dexamethasone: randomised double blind multicentre trial.

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  • 1Department of Anaesthesiology and Intensive Care Medicine, University of Leipzig, D-04103 Leipzig, Germany.

Abstract

OBJECTIVES:

To determine whether 10 mg, 25 mg, or 50 mg metoclopramide combined with 8 mg dexamethasone, given intraoperatively, is more effective in preventing postoperative nausea and vomiting than 8 mg dexamethasone alone, and to assess benefit in relation to adverse drug reactions.

DESIGN:

Four-armed, parallel group, double blind, randomised controlled clinical trial.

SETTING:

Four clinics of a university hospital and four district hospitals in Germany.

PARTICIPANTS:

3140 patients who received balanced or regional anaesthesia during surgery.

MAIN OUTCOME MEASURES:

Postoperative nausea and vomiting within 24 hours of surgery (primary end point); occurrence of adverse reactions.

RESULTS:

Cumulative incidences (95% confidence intervals) of postoperative nausea and vomiting were 23.1% (20.2% to 26.0%), 20.6% (17.8% to 23.4%), 17.2% (14.6% to 19.8%), and 14.5% (12.0% to 17.0%) for 0 mg, 10 mg, 25 mg, and 50 mg metoclopramide. In the secondary analysis, 25 mg and 50 mg metoclopramide were equally effective at preventing early nausea (0-12 hours), but only 50 mg reduced late nausea and vomiting (> 12 hours). The most frequent adverse drug reactions were hypotension and tachycardia, with cumulative incidences of 8.8% (6.8% to 10.8%), 11.2% (9.0% to 13.4%), 12.9% (10.5% to 15.3%), and 17.9% (15.2% to 20.6%) for 0 mg, 10 mg, 25 mg, and 50 mg metoclopramide.

CONCLUSION:

The addition of 50 mg metoclopramide to 8 mg dexamethasone (given intraoperatively) is an effective, safe, and cheap way to prevent postoperative nausea and vomiting. A reduced dose of 25 mg metoclopramide intraoperatively, with additional postoperative prophylaxis in high risk patients, may be equally effective and cause fewer adverse drug reactions.

TRIAL REGISTRATION:

Current Controlled Trials ISRCTN31625370 [controlled-trials.com].

Comment in

PMID:
16861255
[PubMed - indexed for MEDLINE]
PMCID:
PMC1539036
Free PMC Article
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