Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Palonosetron 0.075 mg IV; Dexamethasone 10 mg IV; Promethazine 25 mg IV
Intervention description: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.; At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.; At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
Intervention MeSH terms: Promethazine; Diphenhydramine; Dexamethasone; Palonosetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Palonosetron; Craniotomy; Nausea; Vomiting

Summary:

      Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical
      patients during the first 24 hours after a surgical procedure. The incidence of postoperative
      nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in
      high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of
      this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a
      triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV
      in patients undergoing craniotomies under general anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, 18 to 85 years of age, of any race or gender. With an American Society
             of Anesthesiologist (ASA) physical status of I to III who are scheduled to undergo
             neurological surgery requiring opening of the cranium and Dura matter under general
             anesthesia, at Ohio State University Medical Center and who consent in writing to
             participating in this study.

          -  Post operative hospitalization expected to last at least 72 hours.

          -  Subjects whose surgery is expected to require at least 1 hours of general anesthesia

          -  Subjects who have a negative serum or urine pregnancy test within 1 day of surgery or
             who have been surgically sterilized or are postmenopausal.

        Exclusion Criteria:

          -  Subjects who are prisoners, pregnant, mentally ill, under the age of 18 or over the
             age of 85, ASA classification of V, alcohol or drug abusers.

          -  Subjects with known hypersensitivity to any 5-HT3 antagonist, to any agent that is
             part of the anesthesia regimen, or to other medications to be administered under this
             protocol.

          -  Subjects who are breastfeeding.

          -  Subjects who have had retching/vomiting or moderate to severe nausea in the 24 hours
             prior to anesthesia or suffer chronic nausea and/or vomiting

          -  Subjects who have been treated with any drug or other treatment with anti-emetic
             efficacy within the last 24 hours prior to the start of treatment.

          -  Subjects who have participated in a clinical trial of an investigational drug within
             30 days prior to surgery.

          -  Subjects who are participating in any other clinical study