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OpenTrials
Completed

NCT Number: NCT02317237

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

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.

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Key information

Conditions

Stroke Anesthesia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Revascularization Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

local anesthesia

Procedure

Conscious sedation

Primary outcomes

  1. Growth of DWI lesion

    Time frame: 48-72 hours

Secondary outcomes

  1. Time from arrival to groin puncture and recanalization

    Time frame: 1-2 hours

  2. Blood pressure during intervention

    Time frame: 1-2 hours

  3. Modified Rankin Score

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: GOLIATH

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2014
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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