A randomized blinded study of the incidence of postoperative nausea and vomiting in women after major gynecologic laparoscopic surgery.

STUDY
OBJECTIVE: To estimate the incidence of postoperative nausea and vomiting (PONV) in women undergoing major gynecologic laparoscopic surgery with an expected surgical duration exceeding 1 hour and anticipated overnight hospitalization.
DESIGN: Randomized, double-blind, placebo-controlled study.
SETTING: This study was set at a university hospital. PATIENTS: One hundred forty female patients with an American Society of Anesthesiology (ASA) physical status I or II and scheduled for gynecologic inpatient laparoscopic surgery.
INTERVENTIONS: Patients were randomly assigned to receive 1 mg granisetron (Group A, n=70), or saline solution (Group B, n=70) intravenously after induction of general anesthesia.
MEASUREMENTS AND MAIN RESULTS: The endpoints were evaluated by the following parameters: the incidence of PONV, episodes of nausea, retching, vomiting, rescue antiemetics, and complete response. Patients were closely observed for 24 hours after administration of the study drug. The two groups were generally well balanced in terms of demographic variables. The surgical period was longer in the granisetron group compared with the saline solution group. The total incidence of PONV was 41/70 (59%) in patients who underwent inpatient gynecologic laparoscopic surgery when no prophylactic antiemetic was given. Administration of granisetron decreased the incidence of PONV (29/70 [41%] vs 41/70 [59%], p<.05), the incidence of vomiting (18/70 [26%] vs 31/70 [44%], p<.05), and the proportions of patients requiring rescue antiemetics (14/70 [20%] vs 47/70 [67%], p<.01), but these results were not comparable to other studies.
CONCLUSION: A long surgical period may have great impact on the PONV in women who undergo gynecologic laparoscopic surgery, which implies the need for skilled gynecologic laparoscopists.

RCT Entities:   Population Interventions Outcomes