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

NCT05082896 | Completed DMC

• 1 other identifier: MORPHEUS STROKE REGISTRY
• Study Type: observational
• Target: 453
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mechanical Thrombectomy; General Anesthesia; Conscious Sedation; Posterior Circulation

Outcome Measures

Primary Outcomes (1)

• Functional independence at 3 months

  Rate of functional independence (modified Rankin Scale 0-2) at 3 months

  3 months

Secondary Outcomes (9)

• First Pass Effect

  1 day

• Mortality

  3 months

• Successfull recanalization and complete recanalization according to endovascular technique

  1 day, revascularization grade will be assessed

• Number of passes

  1 day, number of device passes will be assessed

• NIHSS at 24 hours

  24 hours

Study Arms (2)

Conscious Sedation

Procedure: Type of anesthesia choice

General Anesthesia

Procedure: Type of anesthesia choice

Interventions

Type of anesthesia choice PROCEDURE

Use of conscious sedation vs. general anesthesia

Conscious Sedation; General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients eligible for mechanical thrombectomy due to ischemic stroke and presence of arterial occlusion in intracranial posterior circulation

You may qualify if:

• Subject aged ≥ 18 years
• Evidence of posterior arterial occlussion (basilar artery, intracranial vertebral artery and posterior cerebral artery)
• Patients eligible for mechanical thrombectomy

You may not qualify if:

• Patient's refusal to participate
• Arterial recanalization prior to endovascular thrombectomy attempt
• Patient unable to present or be available for follow-up

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Hospital Universitari Doctor Josep Trueta de Girona

Girona, 17007, Spain

Location

Related Publications (11)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 19, 2021
• Study Start: January 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)