Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic Surgeries

February 3, 2009 updated by: Main Line Health

A Randomized, Double-Blind Comparison of Oral Aprepitant and Lower Dose Dexamethasone vs Aprepitant Alone for Preventing Postoperative Nausea and Vomiting After Elective Laparoscopic Surgeries

The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postoperative Nausea and Vomiting (PONV) is a serious and common (50%-70%) complication of laparoscopic abdominal surgery. PONV is multifactorial, and the treatment is multimodal. Preoperative treatment should target the specific mechanism of PONV to minimize its incidence/consequences to the benefit of the patients.

Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P.5 Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response. Dexamethasone is an inexpensive and effective antiemetic drug with minimal side effects after a single-dose administration. The commonly used minimal effective dose is 8 to 10 mg, but the dose 5 mg is suggested for PONV in patients undergoing laparoscopic surgeries. Based on the literature review, occurrence of PONV does not significantly differ at dosing of Dexamethasone equal or higher than 4 mg.

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 and dexamethasone or aprepitant alone preoperatively.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years old
  • ASA physical status I-III
  • must have at least 2 risk factors for PONV

Exclusion Criteria:

  • pregnant or breast feeding patients
  • antiemetic medication in previous 24 hours
  • allergy or other contraindication to study medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator
Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting
Drug: Dexamethasone
Dexamethasone 5 mg administered intravenously following endotracheal intubation
Other Names:
  • EMEND
Drug: Aprepitant
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Other Names:
  • EMEND
PLACEBO_COMPARATOR: Placebo Comparator
Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting
Drug: Aprepitant
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Other Names:
  • EMEND
Drug: Placebo Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidences of nausea, vomiting, need for rescue medication
Time Frame: 1 hour, 2 hours, 24 hours after surgery
1 hour, 2 hours, 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
incidences of unplanned hospital admission; duration of PACU stay
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Main Line Health

Collaborators

Merck Sharp & Dohme LLC
Drexel University College of Medicine

Investigators

  • Principal Investigator: Dmitri Chamchad, MD, Lankenau Hospital, Lankenau Institute for Medical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (ESTIMATE)

February 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Merck-Chamchad-2008
  • Merck #32589

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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