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

NCT ID: NCT02555046

Last Updated: 2015-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-07-31

Brief Summary

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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

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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General Anaesthesia

EVAR-treatment is preformed with the patient in General Anaesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Local Anaesthesia

EVAR-treatment is preformed with the patient in Local Anesthesia

Group Type EXPERIMENTAL

Local Anesthesia

Intervention Type PROCEDURE

Use of unspecified local anaesthesia (fx lidocain or bupivacaine)

Interventions

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Local Anesthesia

Use of unspecified local anaesthesia (fx lidocain or bupivacaine)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Mads Jacob Niemann

Medical Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mads J Niemann, Student

Role: CONTACT

004560633752

Henning B Nielsen, MD, PhD

Role: CONTACT

Other Identifiers

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H-3-2014-161

Identifier Type: -

Identifier Source: org_study_id

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