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Volume 111, Issue 8, Pages 1569-1575 (August 2004)


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Droperidol and dolasetron alone or in combination for prevention of postoperative nausea and vomiting after vitrectomy

Results presented at: German Congress of Ophthalmic Surgeons, May 8–11, 2003; Nürnberg, Germany.

Leopold H.J Eberhart, MD1Corresponding Author Informationemail address, Astrid M Morin, MD1, Steffen Hoerle, MD2, Hinnerk Wulf, MD1, Götz Geldner, MD1

Received 29 May 2003; accepted 9 January 2004.

Abstract 

Purpose

Droperidol and the new serotonin-3 antagonists are effective drugs for the prophylaxis of postoperative nausea and vomiting (PONV). The aim of this trial was to evaluate whether dolasetron could be a substitute for droperidol, because the Food and Drug Administration has required a Black Box warning on the droperidol package insert.

Design

Randomized, placebo-controlled, double-blinded trial.

Participants

Inpatients undergoing vitreoretinal surgery (standard 3-port pars plana vitrectomy for proliferative diabetic vitreoretinopathy, complicated retinal detachment, or macular disease, such as macular pucker, macular hole, or choroidal neovascularization).

Intervention

Two hundred forty patients (3×80) receiving droperidol (10 μg · kg−1), dolasetron (12.5 mg), or the combination of both drugs administered 5 to 10 minutes before the end of surgery.

Control

Eighty patients received saline placebos as controls.

Methods

Standardized general anesthesia was performed, including benzodiazepine premedication, propofol, atracurium or vecuronium, desflurane in N2O/O2, and a continuous infusion of remifentanil. Postoperative analgesia and antiemetic rescue medication were standardized. Episodes of vomiting, retching, nausea, and the need for additional antiemetics were recorded for 24 hours.

Main outcome measures

Severity of PONV (rated by a standardized scoring algorithm) was analyzed as the main end point of the study using the Kruskal–Wallis test.

Results

Data of 304 patients could be analyzed. Mean severity scores in the placebo, dolasetron, droperidol, and combination groups were 1.21, 0.76, 0.47, and 0.30. Incidences of PONV of any severity were 56%, 40%, 28%, and 18%, respectively. The reduction of the incidence of PONV and its severity was statistically significant in the droperidol group and in the combination group relative to the placebo. Dolasetron alone failed to reduce the incidence of PONV. The combination of dolasetron and droperidol showed an additive antiemetic efficacy.

Conclusion

Low-dose droperidol (10 μg · kg−1) but not dolasetron (12.5 mg) reduced postoperative nausea and vomiting after vitreoretinal surgery. Dolasetron (12.5 mg) is not an equivalent substitute for droperidol.

1 Department of Anesthesiology and Intensive Care, Philipps-University Marburg, Marburg, Germany

2 Department of Ophthalmology, Philipps-University Marburg, Marburg, Germany

Corresponding Author InformationCorrespondence to Leopold Eberhart, MD, Department of Anesthesia and Intensive Care, Philipps-University of Marburg, D-35033 Marburg, Germany.

 Manuscript no. 230346.

None of the authors had any financial interests in drugs or methods used in this trial.

PII: S0161-6420(04)00520-2

doi:10.1016/j.ophtha.2004.01.031


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