A randomized controlled trial comparing incidences of postoperative nausea and vomiting after laparoscopic cholecystectomy for preoperative intravenous fluid loading, ondansetron, and control groups in a regional hospital setting in a developing country

Abstract

Background: Postoperative nausea and vomiting (PONV) is a common complication in inpatient and outpatient settings. Multimodal approaches have been pursued to minimize this undesirable outcome. Despite consensus guidelines for the management of PONV have been updated and published for many years, data from our pilot study showed that patients with high-risk surgeries for PONV, laparoscopic cholecystectomy (LC), still hardly received perioperative PONV prophylaxis. This study aimed to compare the incidences of PONV in adult patients undergoing elective LC who were administered preoperative intravenous fluid loading, ondansetron, or neither fluid nor ondansetron in the setting of a regional hospital in a developing country.

Methods: The study was designed as a prospective randomized controlled trial. The total of 171 patients was allocated to three groups: one received fluid loading with Ringer's lactate solution before the operation; the second received ondansetron; and the third group received neither.

Results: In total, 156 patients were analyzed. Their demographic data, history of motion sickness/PONV, and smoking status were not significantly different. The overall incidences of PONV within 24 hours of surgery were 29.1% in the fluid group, 18.4% in the ondansetron group, and 25% in the control group, but the difference was not statistically significant (P = .442). In subgroup analysis, the incidences of PONV and PON in patients younger than 50 years old were significantly different among the three groups (P = .008). A post hoc analysis showed that patients under 50 years in the ondansetron group had significantly lower incidences of PONV and PON than those in the control and fluid groups. However, the incidences of morphine consumption and dizziness in the ondansetron group were significantly higher than those of the two other groups.

Conclusions: Neither the preoperative intravenous fluid loading nor the ondansetron affected PONV in patients aged 50 and older undergoing LC, compared with control. Ondansetron was beneficial for PON prophylaxis in patients under the age of 50, whereas preoperative intravenous fluid loading was considered a risk factor for PON in this population.

Trial registration: ClinicalTrials.gov NCT03141645.