Evaluation of the Role of Preoperative Oral Amisulpride as Part of a Multimodal Antiemetic Prophylaxis Regime on Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy: A Prospective, Double-Blind, Randomized, Placebo-controlled Study.

BACKGROUND

Patients undergoing craniotomy are at high risk for postoperative nausea and vomiting (PONV) despite the use of prophylactic antiemetics. We hypothesized that a single preoperative oral dose of amisulpride as part of a multimodal antiemetic regimen would decrease the incidence of PONV in patients undergoing craniotomy for intracranial tumor surgery.

METHODS

Adult patients scheduled for elective craniotomy requiring general anesthesia were enrolled and randomized to receive either oral amisulpride 25 mg or placebo 2 hours before surgery in addition to our institution's usual antiemetic regimen. The primary outcome of the study was the incidence of nausea and/or vomiting during the first 24 hours postoperatively. Secondary outcomes included severity of nausea, use of rescue antiemetic medications, and treatment-related adverse events.

RESULTS

A total of 100 patients were included in the analysis. More patients in the amisulpride group had no episodes of nausea (90% vs. 40%; P <0.001) and no episodes of vomiting (94% vs. 46%; P <0.001) compared with the placebo group. The severity of nausea was lower in the amisulpride group than in the control group in the first 4 hours after surgery ( P <0.05), and fewer patients receiving amisulpride required rescue antiemetics ( P <0.001). The incidence of treatment-related adverse events was similar between groups.

CONCLUSIONS

A single preoperative oral dose of amisulpride 25 mg as a component of a multimodal antiemetic regimen decreased the incidence and severity of PONV in patients undergoing craniotomy for intracranial tumor surgery, with no adverse effects.