Clinical trial NCT00734929: Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV
nausea
emesis
antiemetics
aprepitant
ondansetron
dexamethasone
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-08-14
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Cumulative Incidence of Emesis
timeFrame: 48 h
Secondary outcomes:
measure: Incidence of Nausea
timeFrame: Post operative procedure (OP) hours (0-2, 24, 48)
measure: Incidence of Vomiting (Post OP)
timeFrame: Post OP (0 - 2 hours)
measure: Incidence of Vomiting (24 Hours)
timeFrame: 24 h
measure: Use of Rescue Antiemetics (Post OP)
timeFrame: Post OP (0 - 2 hours)
measure: Use of Rescue Antiemetics (24 Hours)
timeFrame: 24 h
measure: Use of Rescue Antiemetics (48 Hours)
timeFrame: 48 hour
measure: Number of Participants With a Complete Response Rate
timeFrame: 24 hours Post OP, 48 hours Post OP
measure: Average Nausea Score
timeFrame: Post OP hours 0-2, 24 h, 48 h
measure: Number of Vomiting Episodes
timeFrame: 48 hours
measure: Time to First Vomiting
timeFrame: 48 h
measure: Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"
timeFrame: 48 hour
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ashraf S Habib, MBBCH, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habib AS, Keifer JC, Borel CO, White WD, Gan TJ. 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. Anesth Analg. 2011 Apr;112(4):813-8. doi: 10.1213/ANE.0b013e3181ff47e2. Epub 2010 Nov 16.