NCT01568268

Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Detailed description

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. This study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Conditions

• Laparoscopic Gynecologic, Abdominal, Other Surgery
• General Anesthesia

Interventions

Type	Name	Description
DRUG	Palonosetron	palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS \>= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.
DRUG	placebo control group	placebo intravenous injection over 10 seconds when nausea with NRS \>= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-04-02
• Last updated: 2013-12-25

Locations

4 sites across 1 country: South Korea