HypotensionNCT01669213
Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension
A study testing ramosetron and ondansetron in people with Hypotension and Shivering, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3 receptor antagonists on prevention of hypotension after spinal anesthesia Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypotension, Shivering, Nausea and Vomiting
- What is being tested?
- ramosetron and ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Aug 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing spinal anesthesia
Who cannot join
- hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia
The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3 receptor antagonists on prevention of hypotension after spinal anesthesia
- Conditions
- Hypotension, Shivering, Nausea and Vomiting, Vasopressor
- Being tested
- ramosetron, ondansetron, placebo
- Keywords
- 5-HT3 receptor antagonist, hypotension, spinal anesthesia
- Medical subject headings
- Hypotension, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramosetronDrug
before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg
ondansetronDrug
before 5 minutes spinal anesthesia, injection of ondansetron 8 mg
ondansetronDrug
before 5 minutes spinal anesthesia, injection of ondansetron 4 mg
placeboDrug
before 5 minutes spinal anesthesia, injection of normal saline 5 ml
| Study group | Role | What they receive |
|---|---|---|
| ramosetron 0.3 mg | Active comparator | preparation of ramosetron 0.3 mg Receives: Drug: ramosetron |
| ondansetron 8 mg | Active comparator | preparation of ondansetron 8mg Receives: Drug: ondansetron |
| ondansetron 4 mg | Active comparator | preparation of ondansetron 4mg Receives: Drug: ondansetron |
| non 5-HT3 receptor antagonist | Placebo comparator | preparation of normal saline 5 ml Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
comparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
Measured: up to 30mins after spinal anesthesia
Secondary outcomes (1)
prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure
comparasion of significantly difference in the gap between baseline systolic arterial pressure and lowest systolic arterial pressure measured during 30 minutes after spinal anesthesia and the gap between baseline diastolic arterial pressure and lowest diastolic arterial pressure measured during 30 minutes after spinal anesthesia.
Measured: up to 30mins after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wonsik Ahn, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669213
- Sponsor's protocol ID
- WSAhn_ramosetron_hypotension
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01669213
- Acronym / sponsor ID
- WSAhn_ramosetron_hypotension
- Conditions
- Hypotension, Shivering, Nausea and Vomiting, Vasopressor
- Keywords
- 5-HT3 receptor antagonist, hypotension, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 20 Aug 2012 (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 estimate effects of different kinds, different dose of 5-HT3 receptor antagonists on prevention of hypotension after spinal anesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ramosetron 0.3 mg | Active comparator | Drug: ramosetronpreparation of ramosetron 0.3 mg |
| ondansetron 8 mg | Active comparator | Drug: ondansetronpreparation of ondansetron 8mg |
| ondansetron 4 mg | Active comparator | Drug: ondansetronpreparation of ondansetron 4mg |
| non 5-HT3 receptor antagonist | Placebo comparator | Drug: placebopreparation of normal saline 5 ml |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing spinal anesthesia
Key exclusion criteria (1 listed)
- hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor
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 |
|---|---|---|
| ramosetronbefore 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg | Drug | ramosetron 0.3 mg |
| ondansetronbefore 5 minutes spinal anesthesia, injection of ondansetron 8 mg | Drug | ondansetron 8 mg |
| ondansetronbefore 5 minutes spinal anesthesia, injection of ondansetron 4 mg | Drug | ondansetron 4 mg |
| placebobefore 5 minutes spinal anesthesia, injection of normal saline 5 ml | Drug | non 5-HT3 receptor antagonist |
Primary outcome
prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
Time frame: up to 30mins after spinal anesthesia
comparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
1 secondary outcome
prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure
Time frame: up to 30mins after spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.
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 ondansetron in people with Hypotension and Shivering, 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 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: status not confirmed, as of the sponsor's last update on 20 Aug 2012. 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?
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?
prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia. (time frame: up to 30mins after spinal anesthesia). 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 Aug 2012.