PONVPhase 4NCT03278522
Ramosetron Pre-treatment for PONV and QT Prolongation
A Phase 4 study testing Ramosetron in people with PONV and Prolonged QTc Interval, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared. Read more about this study
- Who is it for?
- Ages 19 to 99 years, women only
- Conditions the study is for
- PONV, Prolonged QTc Interval
- What is being tested?
- Ramosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2017to 28 Feb 2018
- 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 19 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who underwent laparoscopic gynecologic surgery
Who cannot join
- preoperative bradyarrhythmia in ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ramosetron Pre-treatment Time for Postoperative Nausea and Vomiting (PONV) and QTc Prolongation
Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.
Read the detailed description
This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-, and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival to PACU, and 24-h after discharge from PACU.
Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size difference of 0.9.
- Conditions
- PONV, Prolonged QTc Interval
- Being tested
- Ramosetron
- Keywords
- ramosetron
- 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.
RamosetronDrug
Also called ramosetron pre-treatment
Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| ramosetron iv at induction (I) | Active comparator | 0.6mg of ramosetron is given to the patients intravenously at anesthesia induction Receives: Drug: Ramosetron |
| ramosetron iv at recovery (R) | Active comparator | 0.6mg of ramosetron is given to the patients intravenously at end of surgery Receives: Drug: Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc interval change
Difference of QTc interval from preoperative value
Measured: within 10 min after arrival at PACU, and 24 hour after discharge from PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Jul 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ka Young Rhee, Konkuk University Medical Center
- Investigators
- Ka Young Rhee, MD,PhD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278522
- Sponsor's protocol ID
- KUH1160112
- Status last verified
- Mar 2018
- First submitted
- 6 Sep 2017
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ramosetron Pre-treatment Time for Postoperative Nausea and Vomiting (PONV) and QTc Prolongation
- ClinicalTrials.gov ID
- NCT03278522
- Acronym / sponsor ID
- KUH1160112
- Conditions
- PONV, Prolonged QTc Interval
- Keywords
- ramosetron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 11 Sep 2017 (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.
Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.
Detailed description
This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-, and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival to PACU, and 24-h after discharge from PACU.
Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size difference of 0.9.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ramosetron iv at induction (I) | Active comparator | Drug: Ramosetron0.6mg of ramosetron is given to the patients intravenously at anesthesia induction |
| ramosetron iv at recovery (R) | Active comparator | Drug: Ramosetron0.6mg of ramosetron is given to the patients intravenously at end of surgery |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who underwent laparoscopic gynecologic surgery
Key exclusion criteria (1 listed)
- preoperative bradyarrhythmia in ECG
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 |
|---|---|---|
| RamosetronAlso: ramosetron pre-treatmentIntravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery | Drug | ramosetron iv at induction (I), ramosetron iv at recovery (R) |
Primary outcome
QTc interval change
Time frame: within 10 min after arrival at PACU, and 24 hour after discharge from PACU
Difference of QTc interval from preoperative value
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 9 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for PONV
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
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.
Ka Young Rhee, MD,PhD principal investigator
Konkuk University Medical Center
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 PONV and Prolonged QTc Interval, run by Konkuk University 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 9 Mar 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. 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?
QTc interval change (time frame: within 10 min after arrival at PACU, and 24 hour after discharge from PACU). 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 9 Mar 2018.