HysteroscopyNCT03409835
Effect of Ramosetron on Post-discharge Nausea and Vomiting
A study testing Ramosetron and Normal saline in people with Hysteroscopy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
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 or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Ramosetron and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2018to Jun 2019
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.
Who cannot join
- American Society of Anesthesiologists physical statue 3 or more
- Planned admission after surgery
- Intravenous anesthesia
- During chemotherapy
- Pregnancy or breastfeeding
- Abnormal liver or kidney function
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Hyo-Seok Na, 1087012913, hsknana@gmail.com
About this study
Official title: Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center
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 or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.
- Conditions
- Hysteroscopy
- Being tested
- Ramosetron, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
Ramosetron 0.3 mg is administered after induction of general anesthesia.
Normal salineDrug
Normal saline 2 ml is administered after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Ramosetron | Experimental | Not described Receives: Drug: Ramosetron |
| Control | Placebo comparator | Not described Receives: Drug: Normal saline |
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 (4)
The change of postoperative pain score
Score range is from 0 to 10.
Measured: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the number of postoperative administration of rescue analgesic drug
Measured: Postoperative 30 minute and 3 hour
The change in the number of postoperative administration of rescue antiemetic drug
Measured: Postoperative 30 minute and 3 hour
The change of patient's satisfaction score
Score range is from 0 to 10.
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 posted24 Jan 2018
- Study start1 Mar 2018
- Primary completionFeb 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409835
- Sponsor's protocol ID
- PDNV
- Status last verified
- Apr 2018
- First submitted
- 9 Jan 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center
- ClinicalTrials.gov ID
- NCT03409835
- Acronym / sponsor ID
- PDNV
- Conditions
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 24 Jan 2018 (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.
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 or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.
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 |
|---|---|---|
| Ramosetron | Experimental | Drug: Ramosetron |
| Control | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.
Key exclusion criteria (6 listed)
- American Society of Anesthesiologists physical statue 3 or more
- Planned admission after surgery
- Intravenous anesthesia
- During chemotherapy
- Pregnancy or breastfeeding
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 0.3 mg is administered after induction of general anesthesia. | Drug | Ramosetron |
| Normal salineNormal saline 2 ml is administered after induction of general anesthesia. | Drug | Control |
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
4 secondary outcomes
The change of postoperative pain score
Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the number of postoperative administration of rescue analgesic drug
Time frame: Postoperative 30 minute and 3 hour
The change in the number of postoperative administration of rescue antiemetic drug
Time frame: Postoperative 30 minute and 3 hour
The change of patient's satisfaction score
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 20 Apr 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramosetron and Normal saline in people with Hysteroscopy, run by Seoul National University Bundang 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 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: status not confirmed, as of the sponsor's last update on 20 Apr 2018. 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.
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 Hyo-Seok Na (1087012913, hsknana@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?
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 20 Apr 2018.