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

NCT00659737 | Completed Results

• 1 other identifier: 20071433
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Keywords

Post-operative Nausea and Vomiting (PONV)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Nausea and Vomiting

  0-24 hours

Study Arms (2)

Aprepitant

PLACEBO COMPARATOR

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

Drug: Aprepitant

Scopolamine

ACTIVE COMPARATOR

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

Drug: Scopolamine

Interventions

Aprepitant DRUG

40mg tablet

Also known as: Emend (Aprepitant) + Placebo

Aprepitant

Scopolamine DRUG

1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days

Also known as: Scopolamine + Emend (Aprepitant)

Scopolamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University College of Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Aprepitant; Scopolamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Michael Green
• Organization: Drexel university

micheal.green@drexelmed.edu

215-762-1524

Study Officials

• Jay Horrow, MD

  Drexel University College of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 16, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 15, 2014
• Results First Posted: April 29, 2014

Record last verified: 2013-09

Locations

US (1)