Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy

January 31, 2017 updated by: Duke University

A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy

We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A patient is eligible for inclusion in this study if all of the following criteria apply:

  • Age: 18-75 years of age
  • Surgery: craniotomy under general anesthesia.
  • American Society of Anesthesiologists (ASA) Status: ASA: I, II, or III
  • Language: Fluent in the English language
  • Informed Consent: Written informed consent must be obtained.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:

  • Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results.
  • Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant.
  • Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure.
  • Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential.
  • Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments.
  • Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments.
  • Nausea verbal rating score (VRS): A VRS nausea score > 3 (scale 0-10) in the preoperative holding area before pretreatment with the 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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
Drug: Aprepitant + Dexamethasone
Aprepitant 40 mg + Dexamethasone 10 mg
Active Comparator: 2
Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Drug: Ondansetron + Dexamethasone
Ondansetron 4 mg + Dexamethasone 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Incidence of Emesis
Time Frame: 48 h
Any vomiting or retching
48 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Nausea
Time Frame: Post operative procedure (OP) hours (0-2, 24, 48)
operative procedure
Post operative procedure (OP) hours (0-2, 24, 48)
Incidence of Vomiting (Post OP)
Time Frame: Post OP (0 - 2 hours)
Post OP (0 - 2 hours)
Incidence of Vomiting (24 Hours)
Time Frame: 24 h
Any vomiting or retching
24 h
Use of Rescue Antiemetics (Post OP)
Time Frame: Post OP (0 - 2 hours)
Post OP (0 - 2 hours)
Use of Rescue Antiemetics (24 Hours)
Time Frame: 24 h
24 h
Use of Rescue Antiemetics (48 Hours)
Time Frame: 48 hour
48 hour
Number of Participants With a Complete Response Rate
Time Frame: 24 hours Post OP, 48 hours Post OP
complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.
24 hours Post OP, 48 hours Post OP
Average Nausea Score
Time Frame: Post OP hours 0-2, 24 h, 48 h
Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable
Post OP hours 0-2, 24 h, 48 h
Number of Vomiting Episodes
Time Frame: 48 hours
48 hours
Time to First Vomiting
Time Frame: 48 h
48 h
Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"
Time Frame: 48 hour
Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)
48 hour

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Ashraf S Habib, MBBCH, FRCA, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001404

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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