"GOLIATH" - General Or Local Anaestesia in Intra Arterial THerapy (GOLIATH)

May 2, 2017 updated by: University of Aarhus

Anaesthetic Strategy During Endovascular Therapy: General Anaesthesia or Conscious Sedation ?

Patients suffering a stroke with a large vessel occlusion is often treated intra veneous thrombolyse and on top of that also intra arterial therapy. It is unknown what form of anaestesia is best during intra arterial therapy. The investigators will randomize these patients between general anaestesia and local anaestesia. Outcome will be growth of the ischemic lesion as judged on an MRI scan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NIHSS>10
  • mRS=<2
  • groin puncture<6hours from stroke onset
  • occlusion of ICA, ICA-T, M1, M2

Exclusion Criteria:

  • MRI contraindications
  • GCS<9
  • intubated prior to arrival
  • posterior circulation stroke
  • allergy to anestetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: General Anesthesia
The patients, who will receive general anesthesia during intervention
Experimental: Local Anesthesia
The patients, who will receive local anesthesia/conscious sedation during intervention
Procedure: Local anesthesia
Conscious sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth of DWI lesion
Time Frame: 48-72 hours
48-72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from arrival to groin puncture and recanalization
Time Frame: 1-2 hours
1-2 hours
Blood pressure during intervention
Time Frame: 1-2 hours
1-2 hours
Modified Rankin Score
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2015

Primary Completion (Actual)

May 2, 2017

Study Completion (Actual)

May 2, 2017

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOLIATH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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