Postoperative Nausea and VomitingPhase 4NCT00734929
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
A Phase 4 study testing Aprepitant + Dexamethasone and Ondansetron + Dexamethasone in people with Postoperative Nausea and Vomiting, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Aprepitant + Dexamethasone and Ondansetron + Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Aprepitant + Dexamethasone, Ondansetron + Dexamethasone
- Keywords
- PONV, nausea, emesis, antiemetics, aprepitant, ondansetron, dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant + DexamethasoneDrug
Aprepitant 40 mg + Dexamethasone 10 mg
Ondansetron + DexamethasoneDrug
Ondansetron 4 mg + Dexamethasone 10 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia Receives: Drug: Aprepitant + Dexamethasone |
| 2 | Active comparator | Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia Receives: Drug: Ondansetron + Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Emesis
Any vomiting or retching
Measured: 48 h
Secondary outcomes (11)
Incidence of Nausea
operative procedure
Measured: Post operative procedure (OP) hours (0-2, 24, 48)
Incidence of Vomiting (Post OP)
Measured: Post OP (0 - 2 hours)
Incidence of Vomiting (24 Hours)
Any vomiting or retching
Measured: 24 h
Use of Rescue Antiemetics (Post OP)
Measured: Post OP (0 - 2 hours)
Use of Rescue Antiemetics (24 Hours)
Measured: 24 h
Use of Rescue Antiemetics (48 Hours)
Measured: 48 hour
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.
Measured: 24 hours Post OP, 48 hours Post OP
Average Nausea Score
Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable
Measured: Post OP hours 0-2, 24 h, 48 h
Number of Vomiting Episodes
Measured: 48 hours
Time to First Vomiting
Measured: 48 h
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)
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Ashraf S Habib, MBBCH, FRCA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734929
- Sponsor's protocol ID
- Pro00001404
- Status last verified
- Jan 2017
- First submitted
- 13 Aug 2008
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21081776
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00734929
- Acronym / sponsor ID
- Pro00001404
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV, nausea, emesis, antiemetics, aprepitant, ondansetron, dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 3 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aprepitant + DexamethasoneAprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia |
| 2 | Active comparator | Drug: Ondansetron + DexamethasoneOndansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprepitant + DexamethasoneAprepitant 40 mg + Dexamethasone 10 mg | Drug | 1 |
| Ondansetron + DexamethasoneOndansetron 4 mg + Dexamethasone 10 mg | Drug | 2 |
Primary outcome
Cumulative Incidence of Emesis
Time frame: 48 h
Any vomiting or retching
11 secondary outcomes
Incidence of Nausea
Time frame: Post operative procedure (OP) hours (0-2, 24, 48)
Incidence of Vomiting (Post OP)
Time frame: Post OP (0 - 2 hours)
Incidence of Vomiting (24 Hours)
Time frame: 24 h
Use of Rescue Antiemetics (Post OP)
Time frame: Post OP (0 - 2 hours)
Use of Rescue Antiemetics (24 Hours)
Time frame: 24 h
Use of Rescue Antiemetics (48 Hours)
Time frame: 48 hour
Number of Participants With a Complete Response Rate
Time frame: 24 hours Post OP, 48 hours Post OP
Average Nausea Score
Time frame: Post OP hours 0-2, 24 h, 48 h
Number of Vomiting Episodes
Time frame: 48 hours
Time to First Vomiting
Time frame: 48 h
Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"
Time frame: 48 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21081776Habib 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf S Habib, MBBCH, FRCA principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant + Dexamethasone and Ondansetron + Dexamethasone in people with Postoperative Nausea and Vomiting, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Emesis (time frame: 48 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00734929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.