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

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Rigshospitalet

Status

Unknown

Conditions

Anesthesia

Treatments

Procedure: Local Anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02555046
H-3-2014-161

Details and patient eligibility

About

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.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

General Anaesthesia
No Intervention group
Description:
EVAR-treatment is preformed with the patient in General Anaesthesia
Local Anaesthesia
Experimental group
Description:
EVAR-treatment is preformed with the patient in Local Anesthesia
Treatment:
Procedure: Local Anesthesia

Trial contacts and locations

0

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Central trial contact

Henning B Nielsen, MD, PhD; Mads J Niemann, Student

Data sourced from clinicaltrials.gov

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