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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00734929
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : June 3, 2011
Last Update Posted : March 13, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Aprepitant + Dexamethasone Drug: Ondansetron + Dexamethasone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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

Primary Outcome Measures :
  1. Cumulative Incidence of Emesis [ Time Frame: 48 h ]
    Any vomiting or retching

Secondary Outcome Measures :
  1. Incidence of Nausea [ Time Frame: Post operative procedure (OP) hours (0-2, 24, 48) ]
    operative procedure

  2. Incidence of Vomiting (Post OP) [ Time Frame: Post OP (0 - 2 hours) ]
  3. Incidence of Vomiting (24 Hours) [ Time Frame: 24 h ]
    Any vomiting or retching

  4. Use of Rescue Antiemetics (Post OP) [ Time Frame: Post OP (0 - 2 hours) ]
  5. Use of Rescue Antiemetics (24 Hours) [ Time Frame: 24 h ]
  6. Use of Rescue Antiemetics (48 Hours) [ Time Frame: 48 hour ]
  7. 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.

  8. 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

  9. Number of Vomiting Episodes [ Time Frame: 48 hours ]
  10. Time to First Vomiting [ Time Frame: 48 h ]
  11. 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)

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00734929

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Merck Sharp & Dohme Corp.
Principal Investigator: Ashraf S Habib, MBBCH, FRCA Duke University

Publications of Results:
Responsible Party: Duke University Identifier: NCT00734929     History of Changes
Other Study ID Numbers: Pro00001404
First Posted: August 14, 2008    Key Record Dates
Results First Posted: June 3, 2011
Last Update Posted: March 13, 2017
Last Verified: January 2017

Keywords provided by Duke University:

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Serotonin Antagonists