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

doi:10.1136/bmj.38903.419549.80

BMJ, doi: 10.1136/bmj.38903.419549.80, (Published 21 July 2006)

RESEARCH

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

Jan Wallenborn ¹, Götz Gelbrich ²^*, Detlef Bulst ³, Katrin Behrends ¹, Hasso Wallenborn ⁴, Andrea Rohrbach ¹, Uwe Krause ⁵, Thomas Kühnast ⁶, Martin Wiegel ¹, Derk Olthoff ¹

¹ Department of Anaesthesiology and Intensive Care Medicine, University of Leipzig, D-04103 Leipzig, Germany
² Coordination Centre for Clinical Trials Leipzig, University of Leipzig, D-04107 Leipzig
³ Bad Düben Forest Hospital, D-04849 Bad Düben, Germany
⁴ Wurzen District Hospital, D-04808 Wurzen, Germany
⁵ Grimma District Hospital, D-04668 Grimma, Germany
⁶ Weissenfels District Hospital, D-06667 Weissenfels, Germany

^* Correspondence to: goetz.gelbrich{at}kksl.uni-leipzig.de.

Objectives To determine whether 10 mg, 25 mg, or 50 mg metoclopramidecombined with 8 mg dexamethasone, given intraoperatively, ismore effective in preventing postoperative nausea and vomitingthan 8 mg dexamethasone alone, and to assess benefit in relationto adverse drug reactions.

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

Setting Fourclinics of a university hospital and four district hospitalsin Germany.

Participants 3140 patients who received balancedor regional anaesthesia during surgery.

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

ResultsCumulative incidences (95% confidence intervals) of postoperativenausea 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 secondaryanalysis, 25 mg and 50 mg metoclopramide were equally effectiveat preventing early nausea (0-12 hours), but only 50 mg reducedlate nausea and vomiting (>12 hours). The most frequent adversedrug reactions were hypotension and tachycardia, with cumulativeincidences 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 50mg metoclopramide to 8 mg dexamethasone (given intraoperatively)is an effective, safe, and cheap way to prevent postoperativenausea and vomiting. A reduced dose of 25 mg metoclopramideintraoperatively, with additional postoperative prophylaxisin high risk patients, may be equally effective and cause feweradverse drug reactions.

Trial registration Current ControlledTrials ISRCTN31625370.

(Accepted 31 May 2006)

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Rapid Responses:

Read all Rapid Responses

Fluid therapy and high-dose metoclopramide: Gareth L Ackland
bmj.com, 12 Aug 2006 [Full text]
Single dose metoclopramide and movement disorders: Jane E Alty
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Author's reply: Fluid therapy and high-dose metoclopramide: G�tz Gelbrich
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Author's reply: Single dose metoclopramide and movement disorders: G�tz Gelbrich
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PONV prevention in context: John B Carlisle
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Anaesthetic techniques might be an important confounding factor: Hamzeh Hussein, et al.
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Reply to author: single dose metoclopramide and movement disorders: Jane E Alty
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Author's reply: High dose metoclopromide, cardiovascular side effects and method of administration: G�tz Gelbrich
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Author's reply: First do no harm: G�tz Gelbrich
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Change in current practice: Adam K Yamamoto
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Higher dose metoclopramide is a cheap combination anti-emetic: Kevin D Johnston
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Author's reply: Post operative vomiting: G�tz Gelbrich
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Author's reply: Higher dose metoclopramide is a cheap combination anti-emetic: G�tz Gelbrich
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Author's reply: Anaesthetic techniques might be an important confounding factor: G�tz Gelbrich
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Re: Author's reply: High dose metoclopromide, cardiovascular side effects and method of administration: Arun Sehgal
bmj.com, 22 Aug 2006 [Full text]
Prevention of postoperative nausea and vomiting by metoclopramide combined with dexamethasone: The Concerns of The Orthopaedic Surgeon.: Louisa N Banks, et al.
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Author's reply: The Concerns of The Orthopaedic Surgeon.: G�tz Gelbrich
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Re: Author's reply: The Concerns of The Orthopaedic Surgeon.: Louisa N Banks, et al.
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