General Anesthesia Clinical Trial
Official title:
Multicentre ObseRvational Study in Posterior mecHanical thrombEctomy: conscioUs Sedation vs General aneSthesia: MORPHEUS STROKE REGISTRY
The association of conscious sedation vs. general anesthesia in ischemic stroke with posterior circulation occlusions undergoing endovascular therapy, is istill unknown. No prospective or clinical trials have studied this effect on posterior circulation strokes. The choice of anesthetic regimen is ussually depending on local stroke-team protocols or neurointerventional preference. MORPHEUS Stroke Registry is a prospective multicentre observational study that investigates the association between anestheisa and functional outcome in patients with posterior circulation large vessel occlusion treated endovascularly.
Status | Completed |
Enrollment | 453 |
Est. completion date | June 30, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subject aged = 18 years - Evidence of posterior arterial occlussion (basilar artery, intracranial vertebral artery and posterior cerebral artery) - Patients eligible for mechanical thrombectomy Exclusion Criteria: - Patient's refusal to participate - Arterial recanalization prior to endovascular thrombectomy attempt - Patient unable to present or be available for follow-up |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Doctor Josep Trueta de Girona | Girona |
Lead Sponsor | Collaborator |
---|---|
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta |
Spain,
Bouslama M, Haussen DC, Aghaebrahim A, Grossberg JA, Walker G, Rangaraju S, Horev A, Frankel MR, Nogueira RG, Jovin TG, Jadhav AP. Predictors of Good Outcome After Endovascular Therapy for Vertebrobasilar Occlusion Stroke. Stroke. 2017 Dec;48(12):3252-325 — View Citation
Brinjikji W, Pasternak J, Murad MH, Cloft HJ, Welch TL, Kallmes DF, Rabinstein AA. Anesthesia-Related Outcomes for Endovascular Stroke Revascularization: A Systematic Review and Meta-Analysis. Stroke. 2017 Oct;48(10):2784-2791. doi: 10.1161/STROKEAHA.117. — View Citation
Butt W, Dhillon PS, Podlasek A, Malik L, Nair S, Hewson D, England TJ, Lenthall R, McConachie N. Local anesthesia as a distinct comparator versus conscious sedation and general anesthesia in endovascular stroke treatment: a systematic review and meta-anal — View Citation
Campbell BCV, van Zwam WH, Goyal M, Menon BK, Dippel DWJ, Demchuk AM, Bracard S, White P, Davalos A, Majoie CBLM, van der Lugt A, Ford GA, de la Ossa NP, Kelly M, Bourcier R, Donnan GA, Roos YBWEM, Bang OY, Nogueira RG, Devlin TG, van den Berg LA, Clarenc — View Citation
Cappellari M, Pracucci G, Forlivesi S, Saia V, Nappini S, Nencini P, Inzitari D, Greco L, Sallustio F, Vallone S, Bigliardi G, Zini A, Pitrone A, Grillo F, Musolino R, Bracco S, Tinturini R, Tassi R, Bergui M, Cerrato P, Saletti A, De Vito A, Casetta I, G — View Citation
Gory B, Mazighi M, Labreuche J, Blanc R, Piotin M, Turjman F, Lapergue B; ETIS (Endovascular Treatment in Ischemic Stroke) Investigators. Predictors for Mortality after Mechanical Thrombectomy of Acute Basilar Artery Occlusion. Cerebrovasc Dis. 2018;45(1- — View Citation
Hu G, Shi Z, Li B, Shao W, Xu B. General anesthesia versus monitored anesthesia care during endovascular therapy for vertebrobasilar stroke. Am J Transl Res. 2021 Mar 15;13(3):1558-1567. eCollection 2021. — View Citation
Jadhav AP, Bouslama M, Aghaebrahim A, Rebello LC, Starr MT, Haussen DC, Ranginani M, Whalin MK, Jovin TG, Nogueira RG. Monitored Anesthesia Care vs Intubation for Vertebrobasilar Stroke Endovascular Therapy. JAMA Neurol. 2017 Jun 1;74(6):704-709. doi: 10. — View Citation
Schonenberger S, Henden PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sorensen LH, Ringleb PA, Wick W, Kieser M, Mohlenbruch MA, Rasmussen M, Rentzos A, Bosel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Am — View Citation
Terceno M, Silva Y, Bashir S, Vera-Monge VA, Cardona P, Molina C, Chamorro A, de la Ossa NP, Hernandez-Perez M, Werner M, Camps-Renom P, Rodriguez-Campello A, Canovas D, Purroy F, Serena J; Catalan Stroke Code and Reperfusion Consortium (Cat-SCR). Impact — View Citation
Wu L, Jadhav AP, Chen J, Sun C, Ji K, Li W, Zhao W, Li C, Wu C, Wu D, Ji X. Local anesthesia vs general anesthesia during endovascular therapy for acute posterior circulation stroke. J Neurol Sci. 2020 Sep 15;416:117045. doi: 10.1016/j.jns.2020.117045. Ep — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional independence at 3 months | Rate of functional independence (modified Rankin Scale 0-2) at 3 months | 3 months | |
Secondary | First Pass Effect | Rate of complete successful recanalization (mTICI 2c-3) with one single pass of device | 1 day | |
Secondary | Mortality | Rate of mortality at 3 months | 3 months | |
Secondary | Successfull recanalization and complete recanalization according to endovascular technique | Rate of mTICI 3 and mTICI 2b-3 according to endovascular technique (contact aspiration, stentriever or combined) | 1 day, revascularization grade will be assessed | |
Secondary | Number of passes | Number of intracranial thrombectomy passes to achieve final reperfusion | 1 day, number of device passes will be assessed | |
Secondary | NIHSS at 24 hours | Rate of neurological status at 24 hours, dramatical neurological improvement after mechanical thrombectomy | 24 hours | |
Secondary | Type of anesthesic and outcome | Study of the type of anesthesic choice and complications, time of intubation and | 3 months | |
Secondary | Length of stentretriever and recanalization | Rates of FPE and succesful recanalization according to the length of stentretriever used | 1 day, stentretriever type will be assessed | |
Secondary | Arterial hypotension during anesthesic induction and outcome | Study of arterial hypotension during anesthesic induction and outcome | 3 months | |
Secondary | Bridging therapy and neurologial/functional outcomes | To study the association between bridging therapy and reperfussion rates, neurological status and funtional independence at 3 months. | 1 day, type of previous fibrinolytic use will be assessed |
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