Postoperative NauseaNCT01020903
Aprepitant for Post-operative Nausea
A study testing Aprepitant in people with Postoperative Nausea, run by Northwell Health at 1 site in United States.
Trial summary
Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic cholecystectomy patients.
- Must be able to swallow a pill.
Who cannot join
- Liver failure,
- Age less than 18.
- Pregnancy, breast-feeding.
- Pre-op vomiting.
- Allergy to aprepitant.
- Need for post-op gastric drainage.
- Use of drugs that interact with aprepitant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy
Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.
- Conditions
- Postoperative Nausea
- Being tested
- Aprepitant, Placebo
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantProcedure or surgery
Also called Emend
40 mg po pre-op
PlaceboDrug
Also called Sugar pill
Orally, pre-op
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant | Active comparator | Not described Receives: Procedure: Aprepitant |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Nausea and Vomiting
Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionNov 2010
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 NauseaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Sponsor
- Investigators
- Michael B Silverberg, MD, Principal investigator, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020903
- Sponsor's protocol ID
- 09-045
- Status last verified
- Nov 2023
- First submitted
- 24 Nov 2009
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF. Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established postoperative nausea and vomiting after major gynaecological surgery. Br J Anaesth. 1999 Feb;82(2):274-6. doi: 10.1093/bja/82.2.274.
PubMed 10365008
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01020903
- Acronym / sponsor ID
- 09-045
- Conditions
- Postoperative Nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Posted 4 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant | Active comparator | Procedure: Aprepitant |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Laparoscopic cholecystectomy patients.
- Must be able to swallow a pill.
Key exclusion criteria (7 listed)
- Liver failure,
- Age less than 18.
- Pregnancy, breast-feeding.
- Pre-op vomiting.
- Allergy to aprepitant.
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 |
|---|---|---|
| AprepitantAlso: Emend40 mg po pre-op | Procedure or surgery | Aprepitant |
| PlaceboAlso: Sugar pillOrally, pre-op | Drug | Placebo |
Primary outcome
Post-operative Nausea and Vomiting
Time frame: 1 year
Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10365008Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF. Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established postoperative nausea and vomiting after major gynaecological surgery. Br J Anaesth. 1999 Feb;82(2):274-6. doi: 10.1093/bja/82.2.274.
Related trials for Postoperative Nausea
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
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.
Michael B Silverberg, MD principal investigator
Staten Island University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprepitant in people with Postoperative Nausea, run by Northwell Health 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 2 inclusion and 7 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 22 Nov 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2015). 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?
Post-operative Nausea and Vomiting (time frame: 1 year). 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 NCT01020903, 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 22 Nov 2023.