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Comparison of Aprepitant Versus 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
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring postoperative nausea and vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 18 and 65 years of age
  • American Society of Anesthesiology (ASA) physical status 1-3
  • If on oral contraceptive, must be willing to use back up method for 1 month
  • Must have 2 risk factors for PONV

Exclusion Criteria:

  • History of vomiting due to middle ear infection, nervous system disorder, or other condition
  • Procedure less than 1 hour
  • Pregnant or breast feeding
  • Antiemetic medication in previous 24 hours
  • Narrow-angle glaucoma
  • Allergic to belladonna alkaloids
  • Hypersensitive to barbiturates
  • Prostate hypertrophy
  • Severe hepatic disease
  • On chemotherapy taking aprepitant
  • Fever
  • Sepsis
  • Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin

Sites / Locations

  • Hahnemann University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aprepitant and Scopolamine group

Aprepitant and Scopolamine Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Nausea and Vomiting

Secondary Outcome Measures

Number of Participants With Nausea and Vomiting in PACU
Total Vomiting
Need for Antiemetic Medication

Full Information

First Posted
July 15, 2008
Last Updated
May 1, 2014
Sponsor
Drexel University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00717054
Brief Title
Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Official Title
A Randomized, Double-blind Comparison of Oral Aprepitant Alone vs 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
February 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
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for post-operative nausea and vomiting (PONV) treated with oral aprepitant with or without transdermal scopolamine preoperatively.
Detailed Description
Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P. NK-1 receptors are found on vagal afferents in the gastrointestinal tract and in the nucleus tractus solitaries in the brain. Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response. Scopolamine antagonizes muscarinic type 1 (M1) and histamine type 1 (H1) receptors in the CNS, hypothalamus, and vomiting center. The noradrenergic system is also suppressed resulting in a diminished response to vestibular stimulation. Surgical procedures, opioids, and movement postoperatively all stimulate the vestibular system making scopolamine effective prophylaxis for PONV. In adults undergoing general anesthesia with inhalational anesthetic agents, predictive risk factors for PONV include female sex, history of PONV or motion sickness, nonsmoking status, and the use of postoperative opioids. The frequency of PONV is 10% with zero, 21% with one, 39% with two, 61% with three, and 79% with 4 risk factors. The type of surgery also plays a major role. High risk procedures include intrabdominal, laparoscopic, orthopedic, major gynecologic, thyroid, otolaryngological, neurosurgical, breast, and plastic surgery. Improving PONV prophylaxis would have a profound impact on patient care. Decreasing the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned admissions is beneficial. Recent evidence suggests multiple drug therapy is superior to single agents. The correct preoperative treatment medication is instrumental in the outcome. This 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
postoperative nausea and vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aprepitant and Scopolamine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aprepitant and Scopolamine Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Scopolamine
Other Intervention Name(s)
Scopace, Transdermal scopolamine
Intervention Description
Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Primary Outcome Measure Information:
Title
Number of Participants With Nausea and Vomiting
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Number of Participants With Nausea and Vomiting in PACU
Time Frame
Postoperatively, up to 2 hours
Title
Total Vomiting
Time Frame
24 hours postoperatively
Title
Need for Antiemetic Medication
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 18 and 65 years of age American Society of Anesthesiology (ASA) physical status 1-3 If on oral contraceptive, must be willing to use back up method for 1 month Must have 2 risk factors for PONV Exclusion Criteria: History of vomiting due to middle ear infection, nervous system disorder, or other condition Procedure less than 1 hour Pregnant or breast feeding Antiemetic medication in previous 24 hours Narrow-angle glaucoma Allergic to belladonna alkaloids Hypersensitive to barbiturates Prostate hypertrophy Severe hepatic disease On chemotherapy taking aprepitant Fever Sepsis Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Green, DO
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Principal Investigator
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 Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

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