NauseaPhase 4NCT01013012
Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery
A Phase 4 study testing ramosetron with saline and ramosetron with dexamethasone in people with Nausea and Vomiting, run by Yonsei University.
Trial summary
The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- What is being tested?
- ramosetron with saline and ramosetron with dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Nov 2008
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females
- Ages 18 to 65 years old
Who cannot join
- Patients who is taking steroid or who had been treated for the gastrointestinal disease
- Patients who have troubles with the kidney or liver
- Patients transferring to the ICU after the surgery
- overfat patients
- Patients who had taken antiemetics within 24 hours before the surgery
About this study
The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.
- Being tested
- ramosetron with saline, ramosetron with dexamethasone
- Keywords
- highly susceptible patients following spine surgery
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramosetron with salineDrug
Group A : saline 1 ml, ramosetron 6μg/kg
ramosetron with dexamethasoneDrug
Group B : dexamethasone 4 mg, ramosetron 6μg/kg
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A : saline 1 ml + ramosetron 6μg/kg Receives: Drug: ramosetron with saline |
| Group B | Experimental | Group B : dexamethasone 4 mg + ramosetron 6μg/kg Receives: Drug: ramosetron with dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative nausea and vomiting(PONV)
incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients
Measured: After spinal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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
- None (open label)
- Enrolment
- 94 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
- NCT01013012
- Sponsor's protocol ID
- 4-2007-0388
- Status last verified
- Feb 2012
- First submitted
- 12 Nov 2009
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery
- ClinicalTrials.gov ID
- NCT01013012
- Acronym / sponsor ID
- 4-2007-0388
- Keywords
- highly susceptible patients following spine surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 Nov 2009 (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.
The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: ramosetron with salineGroup A : saline 1 ml + ramosetron 6μg/kg |
| Group B | Experimental | Drug: ramosetron with dexamethasoneGroup B : dexamethasone 4 mg + ramosetron 6μg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females
- Ages 18 to 65 years old
Key exclusion criteria (5 listed)
- Patients who is taking steroid or who had been treated for the gastrointestinal disease
- Patients who have troubles with the kidney or liver
- Patients transferring to the ICU after the surgery
- overfat patients
- Patients who had taken antiemetics within 24 hours before the surgery
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 with salineGroup A : saline 1 ml, ramosetron 6μg/kg | Drug | Group A |
| ramosetron with dexamethasoneGroup B : dexamethasone 4 mg, ramosetron 6μg/kg | Drug | Group B |
Primary outcome
the incidence of postoperative nausea and vomiting(PONV)
Time frame: After spinal surgery
incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients
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 3 Feb 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ramosetron with saline and ramosetron with dexamethasone in people with Nausea and Vomiting, run by Yonsei University.
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 5 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 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
the incidence of postoperative nausea and vomiting(PONV) (time frame: After spinal 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 3 Feb 2012.