Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)

• Status: Completed
• Trial end date: 2009-12-18
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate palonosetron versus ondansetron as rescue medication in subjects that develop postoperative nausea and vomiting (PONV) in the Postanaesthesia Care Unit (PACU).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Ondansetron; Palonosetron

Criteria

Inclusion Criteria:

1. Male or female >=18 years of age.

2. American Society of Anesthesiologists (ASA) physical status 1 to 3.

3. Presence of at least 2 of the following PONV risk factors:

• female gender

• history of PONV and/or currently prone to motion sickness (if the subjects cannot remember their last experience of motion sickness or if they suffered from it as a child, then they will not be classified as "prone")

• non-smoking status (never smoked or quit >=12 months ago)

4. Outpatient undergoing elective laparoscopic gynecological or abdominal surgery

5. Surgery for which anesthesia is expected to last at least 30 minutes

6. General endotracheal anesthesia conducted as outlined in the anesthetic procedures section of the protocol

7. If a subject has a known hepatic, renal or cardiovascular impairment, he/she may be enrolled in this study at the discretion of the Investigator

8. If a subject has or may develop prolongation of cardiac conduction intervals, particularly QTc, he/she may be enrolled at the discretion of the Investigator.

9. If a subject is female of childbearing potential, she must be using reliable contraceptive measures and have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours prior to surgery on Day 1. Reliable contraceptive measures include implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence. Non-childbearing potential is defined as post-menopausal for at least 2 years or documented surgical sterilization or hysterectomy at least 3 months before study start.

Exclusion Criteria:

1. Inability to understand or cooperate with the study procedures as determined by the Investigator.

2. 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 72 hours prior to surgery on Day 1.

3. A cancer patient who has had chemotherapy within 4 weeks prior to study entry (Screening visit).

4. Any kind of emetogenic radiotherapy within 8 weeks prior to study entry (Screening visit).

5. Has received any investigational drugs within 30 days before study entry.

6. Having taken any drug with potential antiemetic efficacy within 24 hours prior to anesthetic procedures.

7. Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia .

8. Body mass index (BMI) > 40.

9. Known or suspected current history of alcohol abuse or drug abuse.

10. Known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients.

11. Epileptic patients.

12. Any condition, which in the opinion of the Investigator would make the subject ineligible for participation in the study.