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

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aprepitant
Scopolamine
Sponsored by
Drexel University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea focused on measuring Post-operative Nausea and Vomiting (PONV)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient must be between 18 and 65 years of age.
  • Patient's ASA (American Society of Anesthesiologist) class must be between 1 and 3.
  • If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study.

  • Patient must have 1 FACTOR to qualify

    • Female Sex
    • History of PONV
    • Motion Sickness
    • Non-Smoker
    • Intended Use of Post Operative Opioids

Exclusion Criteria:

  • Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition.
  • The surgical procedure is less than 1 hour.
  • The patient is pregnant or breast feeding.
  • The patient has taken antiemetic medication in previous 24 hours.
  • Patients with narrow-angle glaucoma.
  • Allergy to belladonna alkaloids.
  • Hypersensitivity to barbiturates.

  • Patient taking any of the following medications:

    • Orap
    • Seldane
    • Hismanal
    • Propulsid
    • Phenytoin
    • Phenothiazines
    • Tricyclic Antidepressants
    • Meperidine
    • Tolbutamide
    • Aluminum and Magnesium Trisilicate-containing Antacids
    • Anti-Cholinergics
    • Coumadin
  • Male patients with prostate hypertrophy.
  • Patients with severe hepatic disease.
  • Patients on Chemotherapy and taking Aprepitant.
  • Patients with fever.
  • Patients with sepsis.

Sites / Locations

  • Hahnemann University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Aprepitant

Scopolamine

Arm Description

Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo

Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.

Outcomes

Primary Outcome Measures

Number of Participants With Postoperative Nausea and Vomiting

Secondary Outcome Measures

Full Information

First Posted
April 8, 2008
Last Updated
May 1, 2014
Sponsor
Drexel University College of Medicine
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00659737
Brief Title
Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Official Title
A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University College of Medicine
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.
Detailed Description
Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Post-operative Nausea and Vomiting (PONV)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aprepitant
Arm Type
Placebo Comparator
Arm Description
Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo
Arm Title
Scopolamine
Arm Type
Active Comparator
Arm Description
Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend (Aprepitant) + Placebo
Intervention Description
40mg tablet
Intervention Type
Drug
Intervention Name(s)
Scopolamine
Other Intervention Name(s)
Scopolamine + Emend (Aprepitant)
Intervention Description
1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Nausea and Vomiting
Time Frame
0-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be between 18 and 65 years of age. Patient's ASA (American Society of Anesthesiologist) class must be between 1 and 3. If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study. Patient must have 1 FACTOR to qualify Female Sex History of PONV Motion Sickness Non-Smoker Intended Use of Post Operative Opioids Exclusion Criteria: Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition. The surgical procedure is less than 1 hour. The patient is pregnant or breast feeding. The patient has taken antiemetic medication in previous 24 hours. Patients with narrow-angle glaucoma. Allergy to belladonna alkaloids. Hypersensitivity to barbiturates. Patient taking any of the following medications: Orap Seldane Hismanal Propulsid Phenytoin Phenothiazines Tricyclic Antidepressants Meperidine Tolbutamide Aluminum and Magnesium Trisilicate-containing Antacids Anti-Cholinergics Coumadin Male patients with prostate hypertrophy. Patients with severe hepatic disease. Patients on Chemotherapy and taking Aprepitant. Patients with fever. Patients with sepsis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Horrow, MD
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

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

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