Day SurgeryPhase 4NCT04297293
Ramosetron OD Tablet and Postdischarge Nausea and Vomiting
A Phase 4 study testing Ramosetron in people with Day Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Day Surgery
- What is being tested?
- Ramosetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2020to 28 Feb 2022
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery
Who cannot join
- Pregnancy or breastfeeding
- Patients who are taking other serotonin receptor antagonists
- Patients who have galactose intolerance or Lapp lactase deficiency
- patients who have glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Hyun-Jung Shin, Ph.D., M.D., 82317877499, hjshin.anesth@gmail.com
About this study
Official title: Effects of Ramosetron Orally Disintegrating Tablet on the Prophylaxis of Postdischarge Nausea and Vomiting in High-risk Patients Undergoing Day Surgery Under General Anesthesia
Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.
- Conditions
- Day Surgery
- Being tested
- Ramosetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
Ramosetron orally disintegrating tablet 0.1 mg is administered after discharge (postoperative day 1 and day 2)
| Study group | Role | What they receive |
|---|---|---|
| Ramosetron-ODT | Experimental | Not described Receives: Drug: Ramosetron |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the occurrence of postoperative nausea
Measured: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the occurrence of postoperative vomiting
Measured: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Secondary outcomes (3)
The change in the severity of postoperative nausea
Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)
Measured: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change of patient's satisfaction score
Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)
Measured: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the number of postoperative administration of rescue antiemetic drug
Measured: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start12 May 2020
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
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 Day SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Jung Shin, Seoul National University Hospital
- Investigators
- Hyun-Jung Shin, MD., PhD., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297293
- Sponsor's protocol ID
- B-2002/594-003
- Status last verified
- Dec 2021
- First submitted
- 2 Mar 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shin HJ, Park YH, Chang M, Chae YJ, Lee HT, Lee OH, Min SK, Do SH. Effects of ramosetron orally disintegrating tablets on the prophylaxis of post-discharge nausea and/or vomiting in female patients undergoing day surgery under general anesthesia: a randomized controlled trial. Perioper Med (Lond). 2022 May 12;11(1):17. doi: 10.1186/s13741-022-00251-6.
PubMed 35546414
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ramosetron Orally Disintegrating Tablet on the Prophylaxis of Postdischarge Nausea and Vomiting in High-risk Patients Undergoing Day Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04297293
- Acronym / sponsor ID
- B-2002/594-003
- Conditions
- Day Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 5 Mar 2020 (actual)
- 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.
Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramosetron-ODT | Experimental | Drug: Ramosetron |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding
- Patients who are taking other serotonin receptor antagonists
- Patients who have galactose intolerance or Lapp lactase deficiency
- patients who have glucose-galactose malabsorption
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 |
|---|---|---|
| RamosetronRamosetron orally disintegrating tablet 0.1 mg is administered after discharge (postoperative day 1 and day 2) | Drug | Ramosetron-ODT |
Primary outcome
The change in the occurrence of postoperative nausea
Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the occurrence of postoperative vomiting
Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
3 secondary outcomes
The change in the severity of postoperative nausea
Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change of patient's satisfaction score
Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the number of postoperative administration of rescue antiemetic drug
Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 35546414Shin HJ, Park YH, Chang M, Chae YJ, Lee HT, Lee OH, Min SK, Do SH. Effects of ramosetron orally disintegrating tablets on the prophylaxis of post-discharge nausea and/or vomiting in female patients undergoing day surgery under general anesthesia: a randomized controlled trial. Perioper Med (Lond). 2022 May 12;11(1):17. doi: 10.1186/s13741-022-00251-6.
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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.
Hyun-Jung Shin, MD., PhD. principal investigator
Seoul National University Bundang Hospital
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 in people with Day Surgery, run by Seoul National University Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 22 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Jung Shin, MD., PhD. (82317877499, hjshin.anesth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the occurrence of postoperative nausea (time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour). The study lists 2 primary outcomes in all. 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 NCT04297293, 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 Dec 2021.