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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sergio Bergese, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01474915
First received: November 8, 2011
Last updated: November 8, 2013
Last verified: November 2013
  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
Postoperative Nausea and Vomiting (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:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia [ 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 (PONV) 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.

    Complete Control is defined as no emetic episode, no need for rescue medication and no more than mild nausea overall after neurological surgery and general anesthesia.

    Complete Response is defined as no vomiting and no rescue therapy after neurological surgery and general anesthesia.



Secondary Outcome Measures:
  • Post Operative Nausea and Vomiting (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 (PONV) in high risk patients during a delayed period after neurological surgery under general anesthesia.

    - Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery.

    Nausea is evaluated by a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Vomiting is evaluated by the investigator or nursing staff numerically as either 0, no vomiting;, 1, mild vomiting;, 2, moderate vomiting;, or 3, severe vomiting.



Enrollment: 122
Study Start Date: June 2007
Study Completion Date: April 2013
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. American Society of Anesthesiologist (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474915

Locations
United States, Ohio
The Ohio State University Wexner Medical Center
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
Results First Received: April 30, 2013
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Neurosurgery

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Aprepitant
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Diphenhydramine
Fosaprepitant
Ondansetron
Promethazine
Anesthetics
Anesthetics, Local
Anti-Allergic Agents
Anti-Anxiety Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents

ClinicalTrials.gov processed this record on November 25, 2014