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Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting

This study is currently recruiting participants.
Verified September 2012 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Sergio Bergese, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01474915
First received: November 8, 2011
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

This study is being done to determine the efficacies of two preventative drug combinations for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this study is to compare the efficacy of using aprepitant instead of ondansetron in combination with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By completing this comparison study investigators will determine the most efficacious drug combination which will allow us to enhance the overall comfort and satisfaction of neurosurgical patients in the immediate postoperative period.


Condition Intervention Phase
PONV
Nausea
 Drug: Aprepitant
Drug: Ondansetron
Drug: Promethazine
Drug: Dexamethasone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • PONV scores on a verbal response scale [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]

    To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting in high risk patients during the first 24 hours after neurological surgery under general anesthesia.

    • Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia
    • Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery.


Secondary Outcome Measures:
  • PONV scores on a verbal response scale [ Time Frame: 72 hours post-operatively ] [ Designated as safety issue: No ]

    To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operate nausea and vomiting in high risk patients during a delayed period after neurological surgery under general anesthesia.

    • Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia.
    • Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery.


Estimated Enrollment: 200
Study Start Date: June 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aprepitant

Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.

Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV

 Drug: Aprepitant
Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction
Other Name: Emend
Drug: Promethazine
Subject will receive 25 mg of Promethazine IV around anesthesia induction
Other Names:
  • •Pentazine
  • •Phenadoz
  • •Phenergan
  • •Phenergan Fortis
  • •Promacot
  • •Promethegan
Drug: Dexamethasone
Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Other Names:
  • Decadron
  • Dexpak
Active Comparator: Ondansetron

Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.

Triple therapy

4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV

 Drug: Ondansetron
Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction
Other Name: Zofran
Drug: Promethazine
Subject will receive 25 mg of Promethazine IV around anesthesia induction
Other Names:
  • •Pentazine
  • •Phenadoz
  • •Phenergan
  • •Phenergan Fortis
  • •Promacot
  • •Promethegan
Drug: Dexamethasone
Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Other Names:
  • Decadron
  • Dexpak

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients
  • 18 to 85 years of age
  • Scheduled for neurosurgery requiring opening of the cranium and dura at Ohio State University Medical Center and who consent in writing to participate in this study are eligible.

Exclusion Criteria:

  • Patients will be excluded from this study if they are

    1. prisoners
    2. pregnant women
    3. mentally ill
    4. under the age of 18 or over the age of 85
    5. ASA classification V
    6. alcohol or drug abusers
    7. have a cerebral perfusion pressure (CPP) greater than 150 mmHg or less than 50 mmHg.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474915

Contacts
Contact: Alberto A Uribe, M.D. 614-293-3559 Alberto.Uribe@osumc.edu
Contact: Andrew Otey, B.S. 614-293-3559

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Sergio Bergese
Investigators
Principal Investigator: Sergio D Bergese, M.D. Ohio State University
  More Information

No publications provided

Responsible Party: Sergio Bergese, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01474915     History of Changes
Other Study ID Numbers: 2007H0053
Study First Received: November 8, 2011
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Neurosurgery

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Promethazine
Ondansetron
Diphenhydramine
Dexamethasone
Aprepitant
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antipruritics
Dermatologic Agents
Therapeutic Uses
 Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 18, 2013