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

General Anesthesia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01568268
Study type Interventional
Source Samsung Medical Center
Contact
Status Completed
Phase Phase 3
Start date January 2012
Completion date June 2012
View Details
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