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Multicentre ObseRvational Study in Posterior mecHanical thrombEctomy: conscioUs Sedation vs General aneSthesia

NCT05082896 — Completed, 453 participants, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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Multicentre ObseRvational Study in Posterior mecHanical thrombEctomy: conscioUs Sedation vs General aneSthesia: MORPHEUS STROKE REGISTRY

RegistryNCT05082896
StatusCompleted
Study typeObservational
Enrollment453 (Actual)
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other)
ConditionsMechanical Thrombectomy, General Anesthesia, Conscious Sedation, Posterior Circulation
InterventionsType of anesthesia choice (Procedure)
Datesstart 2021-01-01, primary completion 2023-03-30, completion 2023-06-30, first posted 2021-10-19, last updated 2024-03-08
Locations1 site in Spain

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-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Conscious SedationProcedure: Type of anesthesia choice
General AnesthesiaProcedure: Type of anesthesia choice
  • Type of anesthesia choice (Procedure): Use of conscious sedation vs. general anesthesia

+Outcome measures

Primary outcomes

  • Functional independence at 3 months [3 months]: Rate of functional independence (modified Rankin Scale 0-2) at 3 months

Secondary outcomes

  • First Pass Effect [1 day]: Rate of complete successful recanalization (mTICI 2c-3) with one single pass of device
  • Mortality [3 months]: Rate of mortality at 3 months
  • Successfull recanalization and complete recanalization according to endovascular technique [1 day, revascularization grade will be assessed]: Rate of mTICI 3 and mTICI 2b-3 according to endovascular technique (contact aspiration, stentriever or combined)
  • Number of passes [1 day, number of device passes will be assessed]: Number of intracranial thrombectomy passes to achieve final reperfusion
  • NIHSS at 24 hours [24 hours]: Rate of neurological status at 24 hours, dramatical neurological improvement after mechanical thrombectomy
  • Type of anesthesic and outcome [3 months]: Study of the type of anesthesic choice and complications, time of intubation and
  • Length of stentretriever and recanalization [1 day, stentretriever type will be assessed]: Rates of FPE and succesful recanalization according to the length of stentretriever used
  • Arterial hypotension during anesthesic induction and outcome [3 months]: Study of arterial hypotension during anesthesic induction and outcome
  • Bridging therapy and neurologial/functional outcomes [1 day, type of previous fibrinolytic use will be assessed]: To study the association between bridging therapy and reperfussion rates, neurological status and funtional independence at 3 months.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Hospital Universitari Doctor Josep Trueta de GironaGironaSpain

+Publications

  • Results publication: 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. PMID 33841679
  • Results publication: 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. Epub 2020 Jul 16. PMID 32717535
  • Results publication: 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: 10.1001/jamaneurol.2017.0192. PMID 28395002
  • Results publication: 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, Clarencon F, Burns P, Carpenter J, Berkhemer OA, Yavagal DR, Pereira VM, Ducrocq X, Dixit A, Quesada H, Epstein J, Davis SM, Jansen O, Rubiera M, Urra X, Micard E, Lingsma HF, Naggara O, Brown S, Guillemin F, Muir KW, van Oostenbrugge RJ, Saver JL, Jovin TG, Hill MD, Mitchell PJ; HERMES collaborators. Effect of general anaesthesia on functional outcome in patients with anterior circulation ischaemic stroke having endovascular thrombectomy versus standard care: a meta-analysis of individual patient data. Lancet Neurol. 2018 Jan;17(1):47-53. doi: 10.1016/S1474-4422(17)30407-6. Epub 2017 Dec 16. PMID 29263006
  • Results publication: 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):3252-3257. doi: 10.1161/STROKEAHA.117.018270. Epub 2017 Oct 31. PMID 29089457
  • Results publication: 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 of general anesthesia on posterior circulation large vessel occlusions after endovascular thrombectomy. Int J Stroke. 2021 Oct;16(7):792-797. doi: 10.1177/1747493020976247. Epub 2020 Dec 1. PMID 33573525
  • Results publication: 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(1-2):61-67. doi: 10.1159/000486690. Epub 2018 Jan 30. PMID 29393092
  • Results publication: 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 Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455. PMID 31573636
  • Results publication: 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, Gasparotti R, Magoni M, Castellan L, Malfatto L, Menozzi R, Scoditti U, Causin F, Baracchini C, Puglielli E, Casalena A, Ruggiero M, Malatesta E, Comelli C, Chianale G, Lauretti DL, Mancuso M, Lafe E, Cavallini A, Cavasin N, Critelli A, Ciceri EFM, Bonetti B, Chiumarulo L, Petruzzelli M, Giorgianni A, Versino M, Ganimede MP, Tinelli A, Auteri W, Petrone A, Guidetti G, Nicolini E, Allegretti L, Tassinari T, Filauri P, Sacco S, Pavia M, Invernizzi P, Nuzzi NP, Carmela Spinelli M, Amista P, Russo M, Ferrandi D, Corraine S, Craparo G, Mannino M, Simonetti L, Toni D, Mangiafico S. General Anesthesia Versus Conscious Sedation and Local Anesthesia During Thrombectomy for Acute Ischemic Stroke. Stroke. 2020 Jul;51(7):2036-2044. doi: 10.1161/STROKEAHA.120.028963. Epub 2020 Jun 10. PMID 32517584
  • Results publication: 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-analysis. J Neurointerv Surg. 2022 Mar;14(3):221-226. doi: 10.1136/neurintsurg-2021-017360. Epub 2021 Mar 23. PMID 33758063
  • Results publication: 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.117.017786. Epub 2017 Sep 13. PMID 28904228

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