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

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT02317237
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 128
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.8
• Patients Per Site Per Month: 5

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Mar 8, 2015
• Actual Primary Completion Date: May 2, 2017
• Actual Study Completion Date: May 2, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Growth of DWI lesion [48-72 hours]

Secondary Outcome Measures

1. Time from arrival to groin puncture and recanalization [1-2 hours]

2. Blood pressure during intervention [1-2 hours]

3. Modified Rankin Score [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT02317237
• Other Study ID Numbers: GOLIATH
• First Posted: Dec 15, 2014
• Last Update Posted: May 3, 2017
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of May 3, 2017