AnesthesiaNCT02555046
Muscle and Cerebral Oxygenation Under EVAR of AAA: GA vs LA
A study testing Local Anesthesia in people with Anesthesia, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The purpose of this study is to determine the effect of General versus Local Anaesthesia on muscle and cerebral oxygenation under EVAR-treatment in a prospective unblinded randomised controlled trail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Local Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Scheduled procedure
Who cannot join
- allergies for used local anaesthesia
- have had vascular surgery before in the femoral area
- the need for thromboendarterectomy in common femoral artery
- the need for aortouniiliac stent-graft with cross-over bypass
- severe back pain
- expected time of surgery more than 1.5 hour
- cognitive dysfunction making cooperation during procedure impossible
- Femoral amputee
Trial locations and contacts
No sites are listed yet.
Henning B Nielsen, MD, PhD contact
About this study
Official title: Muscle and Cerebral Oxygenation Under Endovascular Aortic Repair (EVAR) of Abdominal Aortic Aneurysm: General Versus Local Anesthesia - an Randomised Controlled Trial Study
The purpose of this study is to determine the effect of General versus Local Anaesthesia on muscle and cerebral oxygenation under EVAR-treatment in a prospective unblinded randomised controlled trail.
- Conditions
- Anesthesia
- Being tested
- Local Anesthesia
- Keywords
- Spectroscopy, Near-Infrared, Endovascular Procedures, Local Anesthesia, General Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local AnesthesiaProcedure or surgery
Use of unspecified local anaesthesia (fx lidocain or bupivacaine)
| Study group | Role | What they receive |
|---|---|---|
| General Anaesthesia | No intervention | EVAR-treatment is preformed with the patient in General Anaesthesia |
| Local Anaesthesia | Experimental | EVAR-treatment is preformed with the patient in Local Anesthesia Receives: Procedure: Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near-Infrared Spectroscopy-determined Cerebral Oxygenation
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Near-Infrared Spectroscopy-determined Muscle oxygenation
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Jacob Niemann, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555046
- Sponsor's protocol ID
- H-3-2014-161
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle and Cerebral Oxygenation Under Endovascular Aortic Repair (EVAR) of Abdominal Aortic Aneurysm: General Versus Local Anesthesia - an Randomised Controlled Trial Study
- ClinicalTrials.gov ID
- NCT02555046
- Acronym / sponsor ID
- H-3-2014-161
- Conditions
- Anesthesia
- Keywords
- Spectroscopy, Near-Infrared, Endovascular Procedures, Local Anesthesia, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 21 Sep 2015 (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 determine the effect of General versus Local Anaesthesia on muscle and cerebral oxygenation under EVAR-treatment in a prospective unblinded randomised controlled trail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anaesthesia | No intervention | –EVAR-treatment is preformed with the patient in General Anaesthesia |
| Local Anaesthesia | Experimental | Procedure: Local AnesthesiaEVAR-treatment is preformed with the patient in Local Anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Scheduled procedure
Key exclusion criteria (8 listed)
- allergies for used local anaesthesia
- have had vascular surgery before in the femoral area
- the need for thromboendarterectomy in common femoral artery
- the need for aortouniiliac stent-graft with cross-over bypass
- severe back pain
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 |
|---|---|---|
| Local AnesthesiaUse of unspecified local anaesthesia (fx lidocain or bupivacaine) | Procedure or surgery | Local Anaesthesia |
Primary outcome
Near-Infrared Spectroscopy-determined Cerebral Oxygenation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Near-Infrared Spectroscopy-determined Muscle oxygenation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
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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.
Henning B Nielsen, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Local Anesthesia in people with Anesthesia, run by Copenhagen University Hospital, Rigshospitalet.
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 8 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 21 Sep 2015. 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.
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 Mads J Niemann, Student (004560633752, mads.jacob.niemann@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near-Infrared Spectroscopy-determined Cerebral Oxygenation (time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days). The study lists 2 primary outcomes in all. 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 21 Sep 2015.