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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aprepitant + Dexamethasone
Ondansetron + Dexamethasone
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring PONV, nausea, emesis, antiemetics, aprepitant, ondansetron, dexamethasone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia

Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia

Outcomes

Primary Outcome Measures

Cumulative Incidence of Emesis
Any vomiting or retching

Secondary Outcome Measures

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

Full Information

First Posted
August 13, 2008
Last Updated
January 31, 2017
Sponsor
Duke University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00734929
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
PONV, nausea, emesis, antiemetics, aprepitant, ondansetron, dexamethasone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Aprepitant + Dexamethasone
Intervention Description
Aprepitant 40 mg + Dexamethasone 10 mg
Intervention Type
Drug
Intervention Name(s)
Ondansetron + Dexamethasone
Intervention Description
Ondansetron 4 mg + Dexamethasone 10 mg
Primary Outcome Measure Information:
Title
Cumulative Incidence of Emesis
Description
Any vomiting or retching
Time Frame
48 h
Secondary Outcome Measure Information:
Title
Incidence of Nausea
Description
operative procedure
Time Frame
Post operative procedure (OP) hours (0-2, 24, 48)
Title
Incidence of Vomiting (Post OP)
Time Frame
Post OP (0 - 2 hours)
Title
Incidence of Vomiting (24 Hours)
Description
Any vomiting or retching
Time Frame
24 h
Title
Use of Rescue Antiemetics (Post OP)
Time Frame
Post OP (0 - 2 hours)
Title
Use of Rescue Antiemetics (24 Hours)
Time Frame
24 h
Title
Use of Rescue Antiemetics (48 Hours)
Time Frame
48 hour
Title
Number of Participants With a Complete Response Rate
Description
complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.
Time Frame
24 hours Post OP, 48 hours Post OP
Title
Average Nausea Score
Description
Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable
Time Frame
Post OP hours 0-2, 24 h, 48 h
Title
Number of Vomiting Episodes
Time Frame
48 hours
Title
Time to First Vomiting
Time Frame
48 h
Title
Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"
Description
Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)
Time Frame
48 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf S Habib, MBBCH, FRCA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21081776
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.
Results Reference
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Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy

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