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CompletedNCT02317237GOLIATHUpdated May 3, 2017

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

A Phase 3 interventional study of Local anesthesia in Stroke, Anesthesia and Cerebral Revascularization, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-03.

Sponsored by University of Aarhus · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Stroke
  • Anesthesia
  • Cerebral Revascularization

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03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 128 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

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Lead sponsor

University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureLocal anesthesia

    Conscious sedation

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What researchers measure

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

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Study locations

1 site
  • Aarhus University Hospital
    Aarhus, 8000, Denmark
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References and documents

Publications

  • Brekenfeld C, Mattle HP, Schroth G. General is better than local anesthesia during endovascular procedures. Stroke. 2010 Nov;41(11):2716-7. doi: 10.1161/STROKEAHA.110.594622. Epub 2010 Oct 7. No abstract available. PubMed 20930156 ↗
  • Gupta R. Local is better than general anesthesia during endovascular acute stroke interventions. Stroke. 2010 Nov;41(11):2718-9. doi: 10.1161/STROKEAHA.110.596015. Epub 2010 Oct 7. No abstract available. PubMed 20930153 ↗
  • Froehler MT, Fifi JT, Majid A, Bhatt A, Ouyang M, McDonagh DL. Anesthesia for endovascular treatment of acute ischemic stroke. Neurology. 2012 Sep 25;79(13 Suppl 1):S167-73. doi: 10.1212/WNL.0b013e31826959c2. PubMed 23008394 ↗
  • Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, Yoo AJ, Hsu DP, Rymer MM, Tayal AH, Zaidat OO, Natarajan SK, Nogueira RG, Nanda A, Tian M, Hao Q, Kalia JS, Nguyen TN, Chen M, Gupta R. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke. 2010 Jun;41(6):1175-9. doi: 10.1161/STROKEAHA.109.574129. Epub 2010 Apr 15. PubMed 20395617 ↗
  • Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2. PubMed 35857365 ↗
  • Sorensen LH, Speiser L, Karabegovic S, Yoo AJ, Rasmussen M, Sorensen KE, Simonsen CZ. Safety and quality of endovascular therapy under general anesthesia and conscious sedation are comparable: results from the GOLIATH trial. J Neurointerv Surg. 2019 Nov;11(11):1070-1072. doi: 10.1136/neurintsurg-2019-014712. Epub 2019 Mar 29. PubMed 30926686 ↗
  • Rasmussen M, Espelund US, Juul N, Yoo AJ, Sorensen LH, Sorensen KE, Johnsen SP, Andersen G, Simonsen CZ. The influence of blood pressure management on neurological outcome in endovascular therapy for acute ischaemic stroke. Br J Anaesth. 2018 Jun;120(6):1287-1294. doi: 10.1016/j.bja.2018.01.039. Epub 2018 Mar 28. PubMed 29793595 ↗
  • Simonsen CZ, Yoo AJ, Rasmussen M, Sorensen KE, Leslie-Mazwi T, Andersen G, Sorensen LH. Magnetic Resonance Imaging Selection for Endovascular Stroke Therapy: Workflow in the GOLIATH Trial. Stroke. 2018 Jun;49(6):1402-1406. doi: 10.1161/STROKEAHA.118.021038. Epub 2018 May 8. PubMed 29739917 ↗
  • Simonsen CZ, Yoo AJ, Sorensen LH, Juul N, Johnsen SP, Andersen G, Rasmussen M. Effect of General Anesthesia and Conscious Sedation During Endovascular Therapy on Infarct Growth and Clinical Outcomes in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Apr 1;75(4):470-477. doi: 10.1001/jamaneurol.2017.4474. PubMed 29340574 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02317237
Responsible party
Sponsor
First posted
Dec 15, 2014
Start date
Mar 8, 2015
Primary completion
May 2, 2017
Completion
May 2, 2017
Last update
May 3, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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