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

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ClinicalTrials.gov Identifier: NCT02317237
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : May 3, 2017
Aarhus University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Anesthesia Cerebral Revascularization Procedure: Local anesthesia Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anaesthetic Strategy During Endovascular Therapy: General Anaesthesia or Conscious Sedation ?
Actual Study Start Date : March 8, 2015
Primary Completion Date : May 2, 2017
Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Growth of DWI lesion [ Time Frame: 48-72 hours ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317237

Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02317237     History of Changes
Other Study ID Numbers: GOLIATH
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: November 2015

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs