Clinical trial NCT02635828: Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis
Official title: Studying the Effectiveness of Triple Therapy With Palonosetron, Dexamethasone and Promethazine for Prevention of Post Operative Nausea and Vomiting in High Risk Patients Undergoing Neurological Surgery and General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: Palonosetron
Craniotomy
Nausea
Vomiting
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2015-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit (SICU) or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 hours for 5 days via direct interview and/or medical charts review.

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

Primary outcomes:
measure: PONV Incidence
timeFrame: 24 hours after end of surgery
Secondary outcomes:
measure: Incidence of Subjects Significant QTc Changes in the EKG
timeFrame: 24 and 120 hours/discharge after end of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Alberto A Uribe, M.D.
role: STUDY_CHAIR
References:
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