NCT01752374

Palonestron, Granisetron and Ramosetron for Prevention of Postoperative Nasea and Voming After Laparoscopic Abdominal Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: Female
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3 antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea and vomiting after laparoscpic abdominal surgery. This study was conducted to determine the efficacy of three 5-HT3 receptor antagonists in the prevention of PONV for laparoscopic surgery in patients receiving PCA IV.

Detailed description

Occurrences of nausea and vomiting, the severity of nausea (VAS), rescue antiemetic drug use, and amount of PCEA infusion and rescue pethidine were monitored after the end of surgery during four time periods: 0-2 h; 2-6 h; 6-24 h; and 24-48 h. Nausea was defined as the subjectively unpleasant sensation associated with awareness of the urge to vomit; vomiting included retching (defined as the laboured spastic, rhythmic contraction of the respiratory muscles without the expulsion of the gastric contents) and vomiting (defined as the forceful expulsion of gastric contents from the mouth) \[11\]. A complete response was defined as no PONV and no need for rescue anti-emetic drug. If two or more episodes of PONV occurred during the study period, a rescue anti-emetic (metoclopramide 10 mg) was given IV. The primary outcome was the incidence of nausea during the study period.

Conditions

• Female Patients Undergoing Laparoscopic Abdominal Surgery

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-01
• First posted: 2012-12-19
• Last updated: 2015-09-01

Locations

1 site across 1 country: South Korea