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


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


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


METHODS
3140 patients who received balanced or regional anaesthesia during surgery.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
Current Controlled Trials ISRCTN31625370 [controlled-trials.com].
Wallenborn
Jan
J
Department of Anaesthesiology and Intensive Care Medicine, University of Leipzig, D-04103 Leipzig, Germany.
Gelbrich
Götz
G
Bulst
Detlef
D
Behrends
Katrin
K
Wallenborn
Hasso
H
Rohrbach
Andrea
A
Krause
Uwe
U
Kühnast
Thomas
T
Wiegel
Martin
M
Olthoff
Derk
D
D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage* / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007430:Intraoperative Care; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control*
D000932:Antiemetics; D003907:Dexamethasone; D008787:Metoclopramide