NCT02555046

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 21, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

August 11, 2015

Last Update Submit

September 18, 2015

Conditions

Anesthesia

Keywords

Spectroscopy, Near-InfraredEndovascular ProceduresLocal AnesthesiaGeneral Anesthesia

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

General Anaesthesia

NO INTERVENTION

EVAR-treatment is preformed with the patient in General Anaesthesia

Local Anaesthesia

EXPERIMENTAL

EVAR-treatment is preformed with the patient in Local Anesthesia

Procedure: Local Anesthesia

Interventions

Local AnesthesiaPROCEDURE

Use of unspecified local anaesthesia (fx lidocain or bupivacaine)

Local Anaesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Scheduled procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Mads J Niemann, Student

CONTACT

004560633752mads.jacob.niemann@regionh.dk

Henning B Nielsen, MD, PhD

CONTACT

henning.morris.bay.nielsen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Student

Study Record Dates

First Submitted

August 11, 2015

First Posted

September 21, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2017

Study Completion

July 1, 2018

Last Updated

September 21, 2015

Record last verified: 2015-08