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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734929
First received: August 13, 2008
Last updated: May 21, 2013
Last verified: April 2011
  Purpose

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 Intervention Phase
Postoperative Nausea and Vomiting
Drug: Aprepitant + Dexamethasone
Drug: Ondansetron + Dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 in Patients Undergoing Craniotomy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Cumulative Incidence of Emesis [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    Any vomiting or retching


Secondary Outcome Measures:
  • Incidence of Nausea [ Time Frame: PACU ] [ Designated as safety issue: No ]
  • Incidence of Nausea [ Time Frame: 24 h ] [ Designated as safety issue: No ]
  • Incidence if Nausea [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • Incidence of Vomiting [ Time Frame: PACU ] [ Designated as safety issue: No ]
  • Incidence of Vomiting [ Time Frame: 24 h ] [ Designated as safety issue: No ]
  • Use of Rescue Antiemetics [ Time Frame: PACU ] [ Designated as safety issue: No ]
  • Use of Rescue Antiemetics [ Time Frame: 24 h ] [ Designated as safety issue: No ]
  • Use of Rescue Antiemetics [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • Complete Response Rate [ Time Frame: PACU, 24 h, 48 h ] [ Designated as safety issue: No ]
  • Nausea Scores [ Time Frame: PACU, 24 h, 48 h ] [ Designated as safety issue: No ]
  • Number of Vomiting Episodes [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • Time to First Vomiting [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 48 h ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734929

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

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734929     History of Changes
Other Study ID Numbers: Pro00001404
Study First Received: August 13, 2008
Results First Received: April 7, 2011
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
PONV
nausea
emesis
antiemetics
aprepitant
ondansetron
dexamethasone

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Ondansetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014