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

Not Applicable

• Conditions: Anesthesia
• Interventions: Procedure: Local Anesthesia

• Registration Number: NCT02555046
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-09-18
• Last Update Submitted: 2015-09-18
• Study First Posted: 2015-09-21
• Last Update Posted: 2015-09-21
• Study Start: 2015-10
• Primary Completion: 2017-08
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anaesthesia	Local Anesthesia	EVAR-treatment is preformed with the patient in Local Anesthesia

Primary Outcome Measures

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