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Completed

NCT Number: NCT00734929

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprepitant + Dexamethasone

Drug

Aprepitant 40 mg + Dexamethasone 10 mg

Ondansetron + Dexamethasone

Drug

Ondansetron 4 mg + Dexamethasone 10 mg

Primary outcomes

  1. Cumulative Incidence of Emesis

    Time frame: 48 h

    Any vomiting or retching

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 14, 2008
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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