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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
Results First Received: April 30, 2013  
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
Conditions: Postoperative Nausea and Vomiting (PONV)
Nausea
Interventions: Drug: Aprepitant
Drug: Ondansetron
Drug: Promethazine
Drug: Dexamethasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was conducted at The Ohio State University Wexner Medical Center. It started in January of 2009 and ended in April of 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Whenever a participant was enrolled into the study but later did not meet all the inclusion/exclusion criteria, they were excluded from the trial before assignment to groups.

Reporting Groups
  Description
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

Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction

Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction

Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction

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

Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction

Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction

Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction


Participant Flow:   Overall Study
    Aprepitant   Ondansetron
STARTED   60   61 
COMPLETED   50   51 
NOT COMPLETED   10   10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction

Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction

Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction

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

Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction

Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction

Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction

Total Total of all reporting groups

Baseline Measures
   Aprepitant   Ondansetron   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   61   121 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   45   47   92 
>=65 years   15   14   29 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.8136  (14.7)   50.15  (16.4)   50.9748  (15.6062) 
Gender 
[Units: Participants]
     
Female   34   28   62 
Male   26   33   59 
Region of Enrollment 
[Units: Participants]
     
United States   60   61   121 


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale   [ Time Frame: 24 hours post-operatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andrew Otey
Organization: The Ohio State University Department of Anesthesiology
phone: 6142933559
e-mail: Andrew.otey@osumc.edu



Responsible Party: Sergio Bergese, 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