Postoperative Nausea and VomitingPhase 4NCT02478645
Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery
A Phase 4 study testing ramosetron 0.3, ramosetron 0.45 and ramosetron 0.6 in people with Postoperative Nausea and Vomiting, run by Yonsei University at 1 site in South Korea.
Trial summary
Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- ramosetron 0.3, ramosetron 0.45 and ramosetron 0.6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jun 2015to 6 Feb 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ
- patient scheduled for elective gynecological laparoscopic surgery.
Who cannot join
- hepatorenal disease
- BMI > 35 kg/m2
- allergy to ramosetron
- gastrointestinal disease
- vomiting within 24h
- administration of antiemetics or opioids within 24h
Show all 9Show fewer
- QT prolongation (QTc > 440ms)
- pregnant
- problem with communication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu
Seoul, Seoul, 120-752
About this study
Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- ramosetron 0.3, ramosetron 0.45, ramosetron 0.6
- 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.
ramosetron 0.3Drug
The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.
ramosetron 0.45Drug
The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.
ramosetron 0.6Drug
The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| ramosetron 0.3 | Experimental | Not described Receives: Drug: ramosetron 0.3 |
| ramosetron 0.45 | Active comparator | Not described Receives: Drug: ramosetron 0.45 |
| ramosetron 0.6 | Active comparator | Not described Receives: Drug: ramosetron 0.6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
incidence of nausea and vomiting during the first 48 h after surgery
Measured: within 48h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start19 Jun 2015
- Primary completion6 Feb 2016
- Study completion6 Feb 2016
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478645
- Sponsor's protocol ID
- 4-2014-1065
- Status last verified
- Jan 2017
- First submitted
- 18 Jun 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02478645
- Acronym / sponsor ID
- 4-2014-1065
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 6 Feb 2016 (actual)
- Study completion
- 6 Feb 2016 (actual)
- First posted
- 23 Jun 2015 (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.
Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ramosetron 0.3 | Experimental | Drug: ramosetron 0.3 |
| ramosetron 0.45 | Active comparator | Drug: ramosetron 0.45 |
| ramosetron 0.6 | Active comparator | Drug: ramosetron 0.6 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ
- patient scheduled for elective gynecological laparoscopic surgery.
Key exclusion criteria (9 listed)
- hepatorenal disease
- BMI > 35 kg/m2
- allergy to ramosetron
- gastrointestinal disease
- vomiting within 24h
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 |
|---|---|---|
| ramosetron 0.3The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery. | Drug | ramosetron 0.3 |
| ramosetron 0.45The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery. | Drug | ramosetron 0.45 |
| ramosetron 0.6The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery. | Drug | ramosetron 0.6 |
Primary outcome
postoperative nausea and vomiting
Time frame: within 48h after surgery
incidence of nausea and vomiting during the first 48 h 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 25 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ramosetron 0.3, ramosetron 0.45 and ramosetron 0.6 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 2 inclusion and 9 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 25 Jan 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 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.
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?
postoperative nausea and vomiting (time frame: within 48h after surgery). 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 25 Jan 2017.