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Completed

NCT Number: NCT02635828

Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palonosetron 0.075 mg IV

Drug

At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.

Other names: Aloxi

Dexamethasone 10 mg IV

Drug

At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.

Other names: Decadron

Promethazine 25 mg IV

Drug

At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.

Other names: Phenergan

Primary outcomes

  1. PONV Incidence

    Time frame: 24 hours after end of surgery

    The incidence of PONV

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Eisai Inc.

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 21, 2015
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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