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

NCT02317237 | Completed Phase 3

• 1 other identifier: GOLIATH
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Anesthesia; Cerebral Revascularization

Outcome Measures

Primary Outcomes (1)

• Growth of DWI lesion

  48-72 hours

Secondary Outcomes (3)

• Time from arrival to groin puncture and recanalization

  1-2 hours

• Blood pressure during intervention

  1-2 hours

• Modified Rankin Score

  90 days

Study Arms (2)

General Anesthesia

NO INTERVENTION

The patients, who will receive general anesthesia during intervention

Local Anesthesia

EXPERIMENTAL

The patients, who will receive local anesthesia/conscious sedation during intervention

Procedure: Local anesthesia

Interventions

Local anesthesia PROCEDURE

Conscious sedation

Local Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (9)

• 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.

  PMID: 20930156 BACKGROUND

• 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.

  PMID: 20930153 BACKGROUND

• 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.

  PMID: 23008394 BACKGROUND

• 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.

  PMID: 20395617 BACKGROUND

• 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.

  PMID: 35857365 DERIVED

• 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.

  PMID: 30926686 DERIVED

• 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.

  PMID: 29793595 DERIVED

• 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.

  PMID: 29739917 DERIVED

• 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.

  PMID: 29340574 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 15, 2014
• Study Start: March 8, 2015
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: May 3, 2017

Record last verified: 2015-11

Locations

DK (1)