Epidural AnesthesiaPhase 4PNUNCT01559285
Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters
A Phase 4 study testing 0.75% ropivacaine concentration, 0.375% ropivacaine concentration and 0.2% ropivacaine concentration in people with Epidural Anesthesia and Ropivacaine Concentration, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
In this trial, the investigators intend to examine whether the concentration of local anesthetics during epidural analgesia could be modulating factor for change of hemodynamics in patients undergoing major upper abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epidural Anesthesia, Ropivacaine Concentration, Hemodynamics
- What is being tested?
- 0.75% ropivacaine concentration, 0.375% ropivacaine concentration and 0.2% ropivacaine concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2011to 19 Apr 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II patients
- 18 to 65 years old
- undergoing major upper abdominal surgery
- planned combined thoracic epidural analgesia and general anesthesia
Who cannot join
- any contraindication to epidural analgesia
- allergy to local anesthetics of the amide type
- communication difficulties that would prevent reliable assessment
- known significant cardiac or respiratory disease
- pregnant
- patients who were not in cardiac sinus rhythm
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, 626770
About this study
In this trial, the investigators intend to examine whether the concentration of local anesthetics during epidural analgesia could be modulating factor for change of hemodynamics in patients undergoing major upper abdominal surgery.
Read the detailed description
One hundred and twenty patients scheduled for major abdominal surgery under TEA combined general anesthesia were randomized in a double-blinded method to receive one of three different concentration study solutions in 8 ml of volume after the induction of anesthesia: 0.75% ropivacaine (60 mg), 0.375% ropivacaine (30 mg), or 0.2% ropivacane (16 mg).
In each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. The acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group.
- Conditions
- Epidural Anesthesia, Ropivacaine Concentration, Hemodynamics
- Being tested
- 0.75% ropivacaine concentration, 0.375% ropivacaine concentration, 0.2% ropivacaine concentration
- Keywords
- epidural, local, ropivacaine, epidural administration, stroke volume variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75% ropivacaine concentrationDrug
0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
0.375% ropivacaine concentrationDrug
0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
0.2% ropivacaine concentrationDrug
0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 0.375% ropivacaine | Active comparator | 0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia Receives: Drug: 0.375% ropivacaine concentration |
| 0.75% ropivacaine | Active comparator | 0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia Receives: Drug: 0.75% ropivacaine concentration |
| 0.2% ropivacaine | Active comparator | 0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia Receives: Drug: 0.2% ropivacaine concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic changes depends on the concentration of ropivacaine
Systolic blood pressure, diastolic blood pressure, MAP, HR, stroke volume, stroke volume, stroke volume index, stroke volume variation, cardiac output, and cardiac index were continuously measured at 5 minute intervals during 1 hour.
Measured: during 1hour after administration of epidural drug dosing
Secondary outcomes (1)
Age based hemodynamic changes depends on the concentration of ropivacaine
In each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. The acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group.
Systolic blood pressure, diastolic blood pressure, MAP, HR, stroke volume, stroke volume, stroke volume index, stroke volume variation, cardiac output, and cardiac index were continuously measured at 5 minute intervals during 1 hour.
Measured: during 1hour after administration of epidural drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study start16 Nov 2011
- Primary completion19 Apr 2013
- Study completion19 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural AnesthesiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Jeong Lee, Pusan National University Hospital
- Investigators
- Hyeon Jeong Lee, PhD, MD, Principal investigator, Dept. of Anesthesia, Pusan National University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559285
- Sponsor's protocol ID
- PNU05-2011-054
- Acronym
- PNU
- Status last verified
- Aug 2017
- First submitted
- 19 Mar 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong JM, Lee HJ, Oh YJ, Cho AR, Kim HJ, Lee DW, Do WS, Kwon JY, Kim H. Observations on significant hemodynamic changes caused by a high concentration of epidurally administered ropivacaine: correlation and prediction study of stroke volume variation and central venous pressure in thoracic epidural anesthesia. BMC Anesthesiol. 2017 Nov 16;17(1):153. doi: 10.1186/s12871-017-0444-x.
PubMed 29145824
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters
- ClinicalTrials.gov ID
- NCT01559285
- Acronym / sponsor ID
- PNU / PNU05-2011-054
- Conditions
- Epidural Anesthesia, Ropivacaine Concentration, Hemodynamics
- Keywords
- epidural, local, ropivacaine, epidural administration, stroke volume variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2011 (actual)
- Primary completion
- 19 Apr 2013 (actual)
- Study completion
- 19 Apr 2013 (actual)
- First posted
- 21 Mar 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.
In this trial, the investigators intend to examine whether the concentration of local anesthetics during epidural analgesia could be modulating factor for change of hemodynamics in patients undergoing major upper abdominal surgery.
Detailed description
One hundred and twenty patients scheduled for major abdominal surgery under TEA combined general anesthesia were randomized in a double-blinded method to receive one of three different concentration study solutions in 8 ml of volume after the induction of anesthesia: 0.75% ropivacaine (60 mg), 0.375% ropivacaine (30 mg), or 0.2% ropivacane (16 mg).
In each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. The acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.375% ropivacaine | Active comparator | Drug: 0.375% ropivacaine concentration0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia |
| 0.75% ropivacaine | Active comparator | Drug: 0.75% ropivacaine concentration0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia |
| 0.2% ropivacaine | Active comparator | Drug: 0.2% ropivacaine concentration0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I or II patients
- 18 to 65 years old
- undergoing major upper abdominal surgery
- planned combined thoracic epidural analgesia and general anesthesia
Key exclusion criteria (6 listed)
- any contraindication to epidural analgesia
- allergy to local anesthetics of the amide type
- communication difficulties that would prevent reliable assessment
- known significant cardiac or respiratory disease
- pregnant
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 |
|---|---|---|
| 0.75% ropivacaine concentration0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia | Drug | 0.75% ropivacaine |
| 0.375% ropivacaine concentration0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia | Drug | 0.375% ropivacaine |
| 0.2% ropivacaine concentration0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia | Drug | 0.2% ropivacaine |
Primary outcome
hemodynamic changes depends on the concentration of ropivacaine
Time frame: during 1hour after administration of epidural drug dosing
Systolic blood pressure, diastolic blood pressure, MAP, HR, stroke volume, stroke volume, stroke volume index, stroke volume variation, cardiac output, and cardiac index were continuously measured at 5 minute intervals during 1 hour.
1 secondary outcome
Age based hemodynamic changes depends on the concentration of ropivacaine
Time frame: during 1hour after administration of epidural drug dosing
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 29 Aug 2017.
- Derived from this study: PubMed 29145824Hong JM, Lee HJ, Oh YJ, Cho AR, Kim HJ, Lee DW, Do WS, Kwon JY, Kim H. Observations on significant hemodynamic changes caused by a high concentration of epidurally administered ropivacaine: correlation and prediction study of stroke volume variation and central venous pressure in thoracic epidural anesthesia. BMC Anesthesiol. 2017 Nov 16;17(1):153. doi: 10.1186/s12871-017-0444-x.
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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.
Hyeon Jeong Lee, PhD, MD principal investigator
Dept. of Anesthesia, Pusan National University, School of Medicine
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 0.75% ropivacaine concentration, 0.375% ropivacaine concentration and 0.2% ropivacaine concentration in people with Epidural Anesthesia and Ropivacaine Concentration, run by Pusan 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 4 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: finished, as of the sponsor's last update on 29 Aug 2017. 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?
hemodynamic changes depends on the concentration of ropivacaine (time frame: during 1hour after administration of epidural drug dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01559285, which also lists 1 linked publication.
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 29 Aug 2017.