Postoperative Nausea and VomitingNCT01440673
Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy
A study testing Aprepitant in people with Postoperative Nausea and Vomiting, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting. NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Aprepitant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use
Who cannot join
- liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications
Trial locations and contacts
1 site in 1 country.
About this study
- Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting.
- NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited.
- We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.
Read the detailed description
123 female patients (ages 21-60) undergoing laparoscopic hysterectomy
- 80mg aprepitant
- 125mg aprepitant
- placebo
Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Aprepitant
- Keywords
- Postoperative Nausea and Vomiting
- 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
Aprepitant 80 mg, Aprepitant 125 mg
| Study group | Role | What they receive |
|---|---|---|
| aprepitant 125mg | Active comparator | NK1 receptor antagonist Receives: Drug: Aprepitant |
| Aprepitant 80 mg | Active comparator | Not described Receives: Drug: Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The numbers (and percentages) of patients who experienced complete response
- The numbers (and percentages) of patients who experienced complete response, i.e. no nausea, retching, vomiting, or need for rescue treatment
- required rescue therapy and peak nausea scores
- Adverse effects in the three treatment groups
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, University of California, San Francisco
- Responsible party
- Principal investigator, Wol Seon Jung, Gachon University Gil Medical Center
- Investigators
- WOL SEON JUNG, M.D. Ph.D., Principal investigator, Gil Medical Center Gachon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440673
- Sponsor's protocol ID
- GIRBA2085
- Status last verified
- Sep 2011
- First submitted
- 20 Sep 2011
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT01440673
- Acronym / sponsor ID
- GIRBA2085
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Asan Medical Center, University of California, San Francisco
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting.
- NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited.
- We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.
Detailed description
123 female patients (ages 21-60) undergoing laparoscopic hysterectomy
- 80mg aprepitant
- 125mg aprepitant
- placebo
Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.
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 125mg | Active comparator | Drug: AprepitantNK1 receptor antagonist |
| Aprepitant 80 mg | Active comparator | Drug: Aprepitant |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use
Key exclusion criteria (1 listed)
- liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications
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 |
|---|---|---|
| AprepitantAprepitant 80 mg, Aprepitant 125 mg | Drug | Aprepitant 80 mg, aprepitant 125mg |
Primary outcome
The numbers (and percentages) of patients who experienced complete response
Time frame: 48 hours postoperatively
* The numbers (and percentages) of patients who experienced complete response, i.e. no nausea, retching, vomiting, or need for rescue treatment * required rescue therapy and peak nausea scores * Adverse effects in the three treatment groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
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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.
WOL SEON JUNG, M.D. Ph.D. principal investigator
Gil Medical Center Gachon University
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 and Vomiting, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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 26 Sep 2011. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The numbers (and percentages) of patients who experienced complete response (time frame: 48 hours postoperatively). 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 26 Sep 2011.