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

NCT00717054 | Completed Results DMC

• 1 other identifier: 00659737
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Keywords

postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Nausea and Vomiting

  24 hours postoperatively

Secondary Outcomes (3)

• Number of Participants With Nausea and Vomiting in PACU

  Postoperatively, up to 2 hours

• Total Vomiting

  24 hours postoperatively

• Need for Antiemetic Medication

  24 hours postoperatively

Study Arms (2)

Aprepitant and Scopolamine group

ACTIVE COMPARATOR

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.

Drug: Aprepitant; Drug: Scopolamine

Aprepitant and Scopolamine Placebo Group

PLACEBO COMPARATOR

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.

Drug: Scopolamine

Interventions

Aprepitant DRUG

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

Also known as: Emend

Aprepitant and Scopolamine group

Scopolamine DRUG

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

Also known as: Scopace, Transdermal scopolamine

Aprepitant and Scopolamine Placebo Group; Aprepitant and Scopolamine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting; Postoperative Nausea and Vomiting

Interventions

Aprepitant; Scopolamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

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, DO
• Organization: Drexel University College of Medicine

michael.green@drexelmed.edu

215-762-7798

Study Officials

• Michael S Green, DO

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 16, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 20, 2014
• Results First Posted: April 29, 2014

Record last verified: 2013-09

Locations

US (1)