Spinal AnesthesiaPhase 4HRVNCT00974961
Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia
A Phase 4 study testing bupivacaine, levobupivacaine in people with Spinal Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- bupivacaine, levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2009to Jul 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Indicated for spinal anesthesia
Who cannot join
- Allergic reaction to local anesthetics
- Coagulopathy
- Severe spinal deformity
- Cardiac diseases
- Metabolic diseases (such as DM, thyroid or adrenal diseases)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch
Yun-Lin County, 640
Shih-Yu Chen, hitantc@gmail.com
About this study
Official title: Comparison of the Effects of Levobupivacaine and Bupivacaine on Heart Rate Variability in Spinal Anesthesia
The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine.
Read the detailed description
Obtain the heart rate variability (in means and standard deviation, including the high frequency, low frequency and its ratio) data of before and after spinal anesthesia with ECG (and Heart Rate Variability Analyzer) in 2 groups. Meanwhile, record the blood pressure on each subject.
- Conditions
- Spinal Anesthesia
- Being tested
- bupivacaine, levobupivacaine
- Keywords
- Levobupivacaine, HRV, Spinal Anesthesia, Responses of ANS to these two drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine, levobupivacaineDrug
intrathecal injection 15~20mg(for Levobupivacaine) or 10~15mg(for Bupivacaine) once
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine | Active comparator | Lumbar puncture with Levobupivacaine for spinal anesthesia Receives: Drug: bupivacaine, levobupivacaine |
| Bupivacaine | Active comparator | Lumbar puncture with Bupivacaine for spinal anesthesia Receives: Drug: bupivacaine, levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRV values
Measured: 5 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shih-Yu Chen, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974961
- Sponsor's protocol ID
- 200903050M
- Acronym
- HRV
- Status last verified
- Mar 2010
- First submitted
- 7 Sep 2009
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Levobupivacaine and Bupivacaine on Heart Rate Variability in Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT00974961
- Acronym / sponsor ID
- HRV / 200903050M
- Conditions
- Spinal Anesthesia
- Keywords
- Levobupivacaine, HRV, Spinal Anesthesia, Responses of ANS to these two drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 11 Sep 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 compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine.
Detailed description
Obtain the heart rate variability (in means and standard deviation, including the high frequency, low frequency and its ratio) data of before and after spinal anesthesia with ECG (and Heart Rate Variability Analyzer) in 2 groups. Meanwhile, record the blood pressure on each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Active comparator | Drug: bupivacaine, levobupivacaineLumbar puncture with Levobupivacaine for spinal anesthesia |
| Bupivacaine | Active comparator | Drug: bupivacaine, levobupivacaineLumbar puncture with Bupivacaine for spinal anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Indicated for spinal anesthesia
Key exclusion criteria (5 listed)
- Allergic reaction to local anesthetics
- Coagulopathy
- Severe spinal deformity
- Cardiac diseases
- Metabolic diseases (such as DM, thyroid or adrenal diseases)
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 |
|---|---|---|
| bupivacaine, levobupivacaineintrathecal injection 15~20mg(for Levobupivacaine) or 10~15mg(for Bupivacaine) once | Drug | Bupivacaine, Levobupivacaine |
Primary outcome
HRV values
Time frame: 5 minutes after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
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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.
Shih-Yu Chen study chair
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 bupivacaine, levobupivacaine in people with Spinal Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 18 Mar 2010. 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 Taiwan. 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 Shih-Yu Chen, M.D. (886-5-5323911 ext. 5202, hitantc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRV values (time frame: 5 minutes after drug administration). 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 18 Mar 2010.