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

doi:10.1136/bmj.38903.419549.80

BMJ 2006;333:324 (12 August), 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, anaesthesiologist¹, Götz Gelbrich, senior biometrician², Detlef Bulst, head of department of anaesthesiology³, Katrin Behrends, anaesthesiologist¹, Hasso Wallenborn, head of department of anaesthesiology⁴, Andrea Rohrbach, anaesthesiologist¹, Uwe Krause, head of department of anaesthesiology⁵, Thomas Kühnast, head of department of anaesthesiology⁶, Martin Wiegel, anaesthesiologist¹, Derk Olthoff, professor¹

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: G Gelbrich goetz.gelbrich{at}kksl.uni-leipzig.de

Abstract

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, randomisedcontrolled clinical trial.

Setting Four clinics of a university hospital and four districthospitals in Germany.

Participants 3140 patients who received balanced or regionalanaesthesia during surgery.

Main outcome measures Postoperative nausea and vomiting within24 hours of surgery (primary end point); occurrence of adversereactions.

Results Cumulative incidences (95% confidence intervals) ofpostoperative 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 wereequally effective at preventing early nausea (0-12 hours), butonly 50 mg reduced late nausea and vomiting (> 12 hours).The most frequent adverse drug reactions were hypotension andtachycardia, 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 wayto prevent postoperative nausea and vomiting. A reduced doseof 25 mg metoclopramide intraoperatively, with additional postoperativeprophylaxis in high risk patients, may be equally effectiveand cause fewer adverse drug reactions.

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

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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
bmj.com, 14 Aug 2006 [Full text]
Post operative nausea and vomiting � a complex issue: Lini Cherian, et al.
bmj.com, 14 Aug 2006 [Full text]
Author's reply: Fluid therapy and high-dose metoclopramide: G�tz Gelbrich
bmj.com, 16 Aug 2006 [Full text]
Author's reply: Single dose metoclopramide and movement disorders: G�tz Gelbrich
bmj.com, 16 Aug 2006 [Full text]
High dose metoclopromide, cardiovascular side effects and method of administration: Arun Sehgal
bmj.com, 16 Aug 2006 [Full text]
First do no harm: John M Roberts
bmj.com, 16 Aug 2006 [Full text]
Post operative vomiting: Janet Metcalfe
bmj.com, 16 Aug 2006 [Full text]
PONV prevention in context: John B Carlisle
bmj.com, 16 Aug 2006 [Full text]
Anaesthetic techniques might be an important confounding factor: Hamzeh Hussein, et al.
bmj.com, 17 Aug 2006 [Full text]
Reply to author: single dose metoclopramide and movement disorders: Jane E Alty
bmj.com, 17 Aug 2006 [Full text]
Author's reply: High dose metoclopromide, cardiovascular side effects and method of administration: G�tz Gelbrich
bmj.com, 17 Aug 2006 [Full text]
Author's reply: First do no harm: G�tz Gelbrich
bmj.com, 17 Aug 2006 [Full text]
Change in current practice: Adam K Yamamoto
bmj.com, 17 Aug 2006 [Full text]
Higher dose metoclopramide is a cheap combination anti-emetic: Kevin D Johnston
bmj.com, 17 Aug 2006 [Full text]
Author's reply: Post operative vomiting: G�tz Gelbrich
bmj.com, 18 Aug 2006 [Full text]
Author's reply: Higher dose metoclopramide is a cheap combination anti-emetic: G�tz Gelbrich
bmj.com, 18 Aug 2006 [Full text]
Author's reply: Anaesthetic techniques might be an important confounding factor: G�tz Gelbrich
bmj.com, 18 Aug 2006 [Full text]
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.
bmj.com, 30 Aug 2006 [Full text]
Author's reply: The Concerns of The Orthopaedic Surgeon.: G�tz Gelbrich
bmj.com, 2 Sep 2006 [Full text]
Re: Author's reply: The Concerns of The Orthopaedic Surgeon.: Louisa N Banks, et al.
bmj.com, 7 Sep 2006 [Full text]
Author's reply II: The Concerns of The Orthopaedic Surgeon.: G�tz Gelbrich
bmj.com, 9 Sep 2006 [Full text]