Clinical trial NCT02317237: "GOLIATH" - General Or Local Anaestesia in Intra Arterial THerapy
Official title: Anaesthetic Strategy During Endovascular Therapy: General Anaesthesia or Conscious Sedation ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Anesthesia
Cerebral Revascularization
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2014-12-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Growth of DWI lesion
timeFrame: 48-72 hours
Secondary outcomes:
measure: Time from arrival to groin puncture and recanalization
timeFrame: 1-2 hours
measure: Blood pressure during intervention
timeFrame: 1-2 hours
measure: Modified Rankin Score
timeFrame: 90 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
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. No abstract available.
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. No abstract available.
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. doi: 10.1212/WNL.0b013e31826959c2.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.