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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02555046
• Other study ID #: H-3-2014-161
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2015
• Last updated: September 18, 2015
• Start date: October 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2015
• Source: Rigshospitalet, Denmark
• Contact: Mads J Niemann, Student
• Phone: 004560633752
• Email: mads.jacob.niemann[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Data Protection AgencyDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: July 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Local Anesthesia
Use of unspecified local anaesthesia (fx lidocain or bupivacaine)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near-Infrared Spectroscopy-determined Cerebral Oxygenation		participants will be followed for the duration of hospital stay, an expected average of 5 days	No
Primary	Near-Infrared Spectroscopy-determined Muscle oxygenation		participants will be followed for the duration of hospital stay, an expected average of 5 days	No