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

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.

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.

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