Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV
Condition: PONV
Intervention: Palonosetron only; Palonosetron with Dexamethasone
Intervention description: The placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination.; Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Palonosetron; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: PONV; Outpatient surgery; Laparoscopic abdominal surgery; Laparoscopic gynecologic surgery

Summary:

      The purpose of this study is to determine if subjects who receive Palonosetron plus
      Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive
      Palonosetron alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has signed an informed consent form

          -  Have an American Society of Anesthesiologists (ASA) Physical Status Classification of
             I, II, or III

          -  Female, 18-55 years old

               -  surgically sterilized, or

               -  pre-menopausal, with a negative pregnancy test within 7 days before study
                  medication administration

          -  Male, 18-55 years old, who has more than 3 risk factors for PONV

          -  Undergoing outpatient laparoscopic gynecological surgery or laparoscopic abdominal
             surgery, scheduled for between 1 and 3 hours duration

          -  Known to have a history of post-operative nausea and vomiting and/or a history of
             motion sickness

          -  Has been a non-smoker for at least the previous 12 consecutive months

          -  Is able and willing to complete a subject diary until the end of the 96 Hour Follow-Up
             Assessment period

          -  Will be available to respond to follow-up by study personnel at 72 and 96 hours post
             emergence from anesthesia

        Exclusion Criteria:

          -  Has an ASA Physical Status Classification of IV or V

          -  Is pregnant or breastfeeding

          -  Has been taking more than 10-15mg of oxycodone, or an equivalent opioid dose, on a
             regular, daily basis, for more than 3 consecutive days before surgery

          -  Has received an investigational drug in the precious 30 days or who is schedule to
             receive any investigational drug during the study period

          -  Has persistent or recurrent nausea and/or vomiting due to other etiologies, including
             but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer,
             increased intracranial pressure, or brain metastases

          -  Experienced retching or vomiting or uncontrolled nausea within 48 hours before
             administration of study drug

          -  Received medication with known or potential antiemetic activity within 24 hours before
             receiving study drug. This includes, but is not limited to: phenothiazines,
             butyrophenones, hydroxyzine, lorazepam, cannabinoids, metoclopramide, corticosteroids
             (with the exception of topical steroids for skin disorder and inhaled steroids for
             respiratory disorders), trimethobenzamide, monoamine oxidase inhibitors, lithium, and
             5-HT3 receptor antagonists. Subjects who might require one or more of these
             medications during the 24-hour treatment period, other than as described in this
             protocol, are also excluded.

               -  Note: benzodiazepines other than lorazepam are allowed within 24 hours before and
                  during study period, but only when used for indications such as anxiety or to
                  induce sleep.

          -  Received radiation therapy to abdomen or pelvis in the 7 days prior to receiving study
             medication and/or will receive radiation therapy to abdomen or pelvis in the
             evaluation period.

          -  Has a history of poorly controlled diabetes mellitus

          -  Has a history of wound dehiscence

          -  Has had an incidence of necrotizing fasciitis, or any similar infectious process,
             within the previous 90 days

          -  Has a know systemic fungal infection, history of tuberculosis, or other mycobacterial
             infection

          -  Is immunocompromised - defined as a white blood cell (WBC) count of <3,000 mm3

          -  Has any current or past medical condition (e.g., vagotomy) and/or require medication
             to treat a condition that could confound the evaluation of the data collected in this
             clinical trail

          -  Has a known hypersensitivity or contraindication to palonosetron hydrochloride or any
             another 5-HT3 receptor antagonist, dexamethasone, or any scheduled anesthetic or
             analgesic agents

          -  Has a known hypersensitivity to fentanyl and/or ketorolac tromethamine