Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

March 24, 2017 updated by: Sergio Bergese, Ohio State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triple therapy PONV prophylaxis
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.
Drug: Palonosetron 0.075 mg IV
At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
Other Names:
  • Aloxi
Drug: Dexamethasone 10 mg IV
At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
Other Names:
  • Decadron
Drug: Promethazine 25 mg IV
At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
Other Names:
  • Phenergan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PONV Incidence
Time Frame: 24 hours after end of surgery
The incidence of PONV
24 hours after end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Subjects Significant QTc Changes in the EKG
Time Frame: 24 and 120 hours/discharge after end of surgery
The incidence of significant QTc prolongation was measured by comparing baseline EKG, 24 hours and 120 hours after surgery
24 and 120 hours/discharge after end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Eisai Inc.

Investigators

  • Study Chair: Alberto A Uribe, M.D., The Ohio State University Wexner Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008H0170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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