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)
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Ondansetron; Palonosetron
Intervention description: Subjects will receive ondansetron 4 mg intravenously (IV) and will be followed for 72 hours.
Ondansetron is a selective 5-HT3 receptor antagonist. It is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin and prevention of postoperative nausea and/or vomiting.; Subjects will receive palonosetron HCl 0.075 mg IV and will be followed for 72 hours.
Palonosetron hydrochloride (Aloxi®) is a potent and selective 5-HT3 receptor antagonist for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, and the prevention of postoperative nausea and vomiting for up to 24 hours following surgery.
Intervention MeSH terms: Ondansetron; Palonosetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PONV; rescue

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).
    

Eligibility 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.