Postoperative Nausea and VomitingPhase 4NCT00888329
Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy
A Phase 4 study testing Aprepitant in people with Postoperative Nausea and Vomiting, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Oct 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective hysterectomy at Mayo Clinic in Arizona
- ASA I, II, or III
Who cannot join
- Pregnancy
- Concomitant bowel surgery other than appendectomy
- Hypersensitivity to study drug or rescue medication
- Preoperative score for nausea greater than 4 out of 10 points
- Severe hepatic insufficiency (Child-Pugh score > 9)
- Any condition which impairs the patient's ability to complete study assessments
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- Intraoperative hemodynamic instability
- ICU admission
- Prolonged postoperative intubation
- Rifampin, carbamazepine, phenytoin, or other drugs which strongly induce CYP3A4 activity
- Other antiemetic within 12 hours prior to surgery
- Participation in a clinical trial using an investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Postoperative Nausea and Vomiting in a Gynecologic Surgery Population: A Randomized Placebo Controlled Trial of Aprepitant NK-1-receptor Antagonist
The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.
Read the detailed description
Postoperative nausea and vomiting (PONV) is the most frequent side effect after anesthesia, occurring in approximately 30% of unselected patients, and can be increased up to 70% in certain populations and procedures. Despite screening for patients at high risk for PONV, current prophylactic interventions fail to completely eliminate PONV for a substantial number of patients, leading to dehydration, electrolyte imbalance, prolonged hospitalizations, multiple doses of rescue therapy, and readmissions to the hospital (2). Aprepitant (Emend) is the first neurokin-1-receptor antagonist in a new class of antiemetics, which has already demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV). Early studies have also suggested it may useful in the prevention of postoperative nausea and vomiting (PONV).
Patients undergoing elective inpatient or outpatient hysterectomy will be offered enrollment in this prospective, randomized, double blinded, placebo controlled trial. Subjects will receive Aprepitant vs. placebo prior to induction of standardized anesthesia. Postoperative nausea (assessed with a VRS), vomiting, and use of rescue antiemetic therapy will be documented over a 48h period. Additionally, hospitalization days and readmissions for PONV will be compared. Adverse events will be reported to the IRB and manufacturer. By reducing PONV in a group of high risk patients, we anticipate a demonstrated decrease in rescue antiemetic costs and hospitalization days for PONV related issues.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Aprepitant, Placebo
- Keywords
- Elective hysterectomy
- 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.
AprepitantDrug
Also called Emend
40 mg administered orally with a sip of water prior to anesthesia induction.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant | Experimental | 40 mg aprepitant Receives: Drug: Aprepitant |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Emesis
This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.
Measured: 24 hours after emergence from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startJul 2007
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Slow accrual.
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.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Javier Magrina, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888329
- Sponsor's protocol ID
- 06-005478
- Status last verified
- Mar 2012
- First submitted
- 24 Apr 2009
- Last updated
- 30 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Nausea and Vomiting in a Gynecologic Surgery Population: A Randomized Placebo Controlled Trial of Aprepitant NK-1-receptor Antagonist
- ClinicalTrials.gov ID
- NCT00888329
- Acronym / sponsor ID
- 06-005478
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Elective hysterectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Posted 30 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.
Detailed description
Postoperative nausea and vomiting (PONV) is the most frequent side effect after anesthesia, occurring in approximately 30% of unselected patients, and can be increased up to 70% in certain populations and procedures. Despite screening for patients at high risk for PONV, current prophylactic interventions fail to completely eliminate PONV for a substantial number of patients, leading to dehydration, electrolyte imbalance, prolonged hospitalizations, multiple doses of rescue therapy, and readmissions to the hospital (2). Aprepitant (Emend) is the first neurokin-1-receptor antagonist in a new class of antiemetics, which has already demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV). Early studies have also suggested it may useful in the prevention of postoperative nausea and vomiting (PONV).
Patients undergoing elective inpatient or outpatient hysterectomy will be offered enrollment in this prospective, randomized, double blinded, placebo controlled trial. Subjects will receive Aprepitant vs. placebo prior to induction of standardized anesthesia. Postoperative nausea (assessed with a VRS), vomiting, and use of rescue antiemetic therapy will be documented over a 48h period. Additionally, hospitalization days and readmissions for PONV will be compared. Adverse events will be reported to the IRB and manufacturer. By reducing PONV in a group of high risk patients, we anticipate a demonstrated decrease in rescue antiemetic costs and hospitalization days for PONV related issues.
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 |
|---|---|---|
| Aprepitant | Experimental | Drug: Aprepitant40 mg aprepitant |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for elective hysterectomy at Mayo Clinic in Arizona
- ASA I, II, or III
Key exclusion criteria (12 listed)
- Pregnancy
- Concomitant bowel surgery other than appendectomy
- Hypersensitivity to study drug or rescue medication
- Preoperative score for nausea greater than 4 out of 10 points
- Severe hepatic insufficiency (Child-Pugh score > 9)
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 administered orally with a sip of water prior to anesthesia induction. | Drug | Aprepitant |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants With Emesis
Time frame: 24 hours after emergence from anesthesia
This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Javier Magrina, MD principal investigator
Mayo Clinic
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 in people with Postoperative Nausea and Vomiting, run by Mayo Clinic 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 12 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: stopped early, as of the sponsor's last update on 30 Mar 2012. 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.
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 30 Mar 2012). 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?
Number of Participants With Emesis (time frame: 24 hours after emergence from anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2012.