A randomized, double-blind comparison of granisetron alone and combined with dexamethasone for post-laparoscopic...

Granisetron hydrochloride, a selective serotonin receptor antagonist, has been used to treat established postoperative nausea and vomiting (PONV). Dexamethasone has been shown to reduce the incidence of chemotherapy-induced emesis when added to an antiemetic regimen.

The aim of this study was to examine the differences in efficacy and tolerability between the combination of granisetron plus dexamethasone and granisetron alone for the treatment of PONV.

This study was a randomized, double-blind trial conducted at Toride Kyodo General Hospital (Toride, Ibaraki, Japan). Men and women aged 25 to 65 years and experiencing emetic symptoms after laparoscopic cholecystectomy were eligible for the study. Patients received IV therapy with either granisetron 40 μg/kg alone or with dexamethasone 8 mg. Patients were observed for 24 hours. Emetic episodes and the need for a rescue antiemetic were recorded by nursing staff, who were blinded to treatment assignment.

One hundred patients (63 women, 37 men; mean [SD] age, 47 [10] years; range, 25-65 years) were enrolled; 50 patients were randomized to each treatment group. No significant differences in baseline demographic or clinical characteristics were observed between the groups. Complete control of established PONV, defined as no emetic symptoms and no need for another rescue antiemetic medication, occurred in significantly more patients who received the combination (49/50 [98%]) than in those who received granisetron alone (41/50 [82%]) (P = 0.008). No clinically important adverse effects due to the study drugs were observed in either group.

In this study population of patients experiencing post-cholecystectomy emesis, the combination of granisetron plus dexamethasone was more efficacious than granisetron alone for the treatment of PONV. Tolerability between the 2 treatments was similar.