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

Phase 3

Completed

• Conditions: Stroke; Anesthesia; Cerebral Revascularization
• Interventions: Procedure: Local anesthesia

• Registration Number: NCT02317237
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Study Start: 2015-03-08
• Status Verified: 2015-11
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anesthesia	Local anesthesia	The patients, who will receive local anesthesia/conscious sedation during intervention

Primary Outcome Measures

Name	Time	Method
Growth of DWI lesion	48-72 hours

Secondary Outcome Measures

Name	Time	Method
Time from arrival to groin puncture and recanalization	1-2 hours
Blood pressure during intervention	1-2 hours
Modified Rankin Score	90 days

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark