Muscle and Cerebral Oxygenation Under EVAR of AAA: GA vs LA

Muscle and Cerebral Oxygenation Under Endovascular Aortic Repair (EVAR) of Abdominal Aortic Aneurysm: General Versus Local Anesthesia - an Randomised Controlled Trial Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02555046

Enrollment

Registered

2015-09-21

Start date

2015-10-31

Completion date

2018-07-31

Last updated

2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Spectroscopy, Near-Infrared, Endovascular Procedures, Local Anesthesia, General Anesthesia

Brief 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.

Interventions

PROCEDURELocal Anesthesia

Use of unspecified local anaesthesia (fx lidocain or bupivacaine)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years or older * Scheduled procedure

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Near-Infrared Spectroscopy-determined Cerebral Oxygenation	participants will be followed for the duration of hospital stay, an expected average of 5 days
Near-Infrared Spectroscopy-determined Muscle oxygenation	participants will be followed for the duration of hospital stay, an expected average of 5 days

Contacts

Primary ContactMads J Niemann, Student

mads.jacob.niemann@regionh.dk004560633752

Backup ContactHenning B Nielsen, MD, PhD

henning.morris.bay.nielsen@regionh.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026