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

Stroke Clinical Trial

— GOLIATH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317237
• Other study ID #: GOLIATH
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2014
• Last updated: May 2, 2017
• Start date: March 8, 2015
• Est. completion date: May 2, 2017

Study information

• Verified date: November 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cerebral Revascularization
• Stroke

Intervention

Procedure:
• Local anesthesia
Conscious sedation

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth of DWI lesion		48-72 hours
Secondary	Time from arrival to groin puncture and recanalization		1-2 hours
Secondary	Blood pressure during intervention		1-2 hours
Secondary	Modified Rankin Score		90 days