Postoperative Nausea and VomitingPhase 4NCT01897337
The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting
A Phase 4 study testing Aprepitant in people with Postoperative Nausea and Vomiting, run by Yonsei University at 1 site in South Korea.
Trial summary
PONV (Postoperative nausea and vomiting) is one of most common complications after general anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing PONV. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Aprepitant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jun 2013
- Phase
- Phase 4
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient undergoing laparoscopic gynecologic surgery.
- Patient who takes fentanyl based IV PCA
- ASA class I-II
Who cannot join
- allergy to aprepitant
- take another antiemetics before surgery
- decreased liver function
- psychological disease
- who cannot speak Korean
- take medicines that interacts with emend who do not agree to the study
Trial locations and contacts
1 site in 1 country.
About this study
PONV (Postoperative nausea and vomiting) is one of most common complications after general anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing PONV. In consequence, patients undergoing laparoscopic gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl based IV-PCA. And it also causes PONV.
So, we should prevent PONV in these patients by using multimodal or combination therapy.
Read more
Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea and vomiting. Many studies using aprepitant to prevent PONV are in progress.
In this study, we investigate the effect of combining aprepitant with ondansetron in high-risk patients for PONV.
- Conditions
- Postoperative Nausea and Vomiting
- 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.
AprepitantDrug
Also called Emend
We administrate aprepitant with small amount of water to aprepitant group in pre treatment room. (Before patient get in the operating room)And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.
placeboDrug
Patient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant group | Experimental | We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room) Receives: Drug: Aprepitant |
| placebo group | Placebo comparator | Patient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of postoperative nausea and vomiting
Severity of PONV will be measured by using verbal numerical rating scale (0-10).
Incidence of retching or vomiting will also be recorded upto 2 days after surgery.
Measured: upto 2 days after surgery
Secondary outcomes (2)
adverse event
abdominal pain, headache, diziness, drowsiness, constipation, pruritus, etc
Measured: upto 2 days after surgery
pain
Pain is assessed with verbal numeric rating scale. (0-10)
Measured: upto 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 Yonsei 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Hee Shim, Yonsei University
- Investigators
- Yon Hee Shim, Study director, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897337
- Sponsor's protocol ID
- 3-2012-0076
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ham SY, Shim YH, Kim EH, Son MJ, Park WS, Lee JS. Aprepitant for antiemesis after laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):90-5. doi: 10.1097/EJA.0000000000000242.
PubMed 26694939
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT01897337
- Acronym / sponsor ID
- 3-2012-0076
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Jul 2013 (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.
PONV (Postoperative nausea and vomiting) is one of most common complications after general anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing PONV. In consequence, patients undergoing laparoscopic gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl based IV-PCA. And it also causes PONV.
So, we should prevent PONV in these patients by using multimodal or combination therapy.
Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea and vomiting. Many studies using aprepitant to prevent PONV are in progress.
In this study, we investigate the effect of combining aprepitant with ondansetron in high-risk patients for PONV.
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 group | Experimental | Drug: AprepitantWe administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room) |
| placebo group | Placebo comparator | Drug: placeboPatient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient undergoing laparoscopic gynecologic surgery.
- Patient who takes fentanyl based IV PCA
- ASA class I-II
Key exclusion criteria (6 listed)
- allergy to aprepitant
- take another antiemetics before surgery
- decreased liver function
- psychological disease
- who cannot speak Korean
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: EmendWe administrate aprepitant with small amount of water to aprepitant group in pre treatment room. (Before patient get in the operating room)And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery. | Drug | Aprepitant group |
| placeboPatient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery. | Drug | placebo group |
Primary outcome
incidence and severity of postoperative nausea and vomiting
Time frame: upto 2 days after surgery
Severity of PONV will be measured by using verbal numerical rating scale (0-10). Incidence of retching or vomiting will also be recorded upto 2 days after surgery.
2 secondary outcomes
adverse event
Time frame: upto 2 days after surgery
pain
Time frame: upto 2 days after surgery
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 11 Jul 2013.
- Derived from this study: PubMed 26694939Ham SY, Shim YH, Kim EH, Son MJ, Park WS, Lee JS. Aprepitant for antiemesis after laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):90-5. doi: 10.1097/EJA.0000000000000242.
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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.
Yon Hee Shim study director
Yonsei 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 in people with Postoperative Nausea and Vomiting, run by Yonsei University 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 3 inclusion and 6 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 11 Jul 2013. 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. 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?
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?
incidence and severity of postoperative nausea and vomiting (time frame: upto 2 days after surgery). 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 NCT01897337, 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 11 Jul 2013.