Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Drexel University
ClinicalTrials.gov Identifier:
NCT00717054
First received: July 15, 2008
Last updated: May 1, 2014
Last verified: September 2013
Results First Received: March 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Nausea
Vomiting
Interventions: Drug: Aprepitant
Drug: Scopolamine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aprepitant and Scopolamine Group

Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.

Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Aprepitant and Placebo Scopolamine Group

Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.

Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery


Participant Flow:   Overall Study
    Aprepitant and Scopolamine Group     Aprepitant and Placebo Scopolamine Group  
STARTED     58     57  
COMPLETED     58     57  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Aprepitant and Scopolamine Group

Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.

Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Aprepitant and Placebo Scopolamine Group

Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.

Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Total Total of all reporting groups

Baseline Measures
    Aprepitant and Scopolamine Group     Aprepitant and Placebo Scopolamine Group     Total  
Number of Participants  
[units: participants]
  58     57     115  
Age  
[units: years]
Mean ± Standard Deviation
  46.3  ± 11.06     47.2  ± 11.27     46.8  ± 11.17  
Gender  
[units: participants]
     
Female     51     52     103  
Male     7     5     12  



  Outcome Measures
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1.  Primary:   Number of Participants With Nausea and Vomiting   [ Time Frame: 24 hours postoperatively ]

2.  Secondary:   Number of Participants With Nausea and Vomiting in PACU   [ Time Frame: Postoperatively, up to 2 hours ]

3.  Secondary:   Total Vomiting   [ Time Frame: 24 hours postoperatively ]

4.  Secondary:   Need for Antiemetic Medication   [ Time Frame: 24 hours postoperatively ]


  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: Michael Green, DO
Organization: Drexel University College of Medicine
phone: 215-762-7798
e-mail: michael.green@drexelmed.edu


No publications provided


Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT00717054     History of Changes
Other Study ID Numbers: 00659737
Study First Received: July 15, 2008
Results First Received: March 5, 2014
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board