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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborators: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Palonosetron

Criteria

Inclusion Criteria:

• 19 years and older, younger than 70 years old

• American society of Anesthesiologists physical status classification I to III

• those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia

• surgery for which anesthesia is expected to last at least 30 minutes

• if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected QT interval, he/she may be enrolled at the discretion of the investigator.

Exclusion Criteria:

• known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient

• inability to understand or cooperate with the study procedures as determined by the investigator

• women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 7 days prior to surgery day 1.

• has received any investigational drug within 30 days before study entry

• having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures.

• any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia

• known or suspected current history of alcohol abuse or drug abuse.

• any condition, which in the opinion of the investigator would make the subject ineligible for participation in the study