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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082896
• Other study ID #: MORPHEUS STROKE REGISTRY
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2024
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• 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

Related Conditions & MeSH terms

• Conscious Sedation
• General Anesthesia
• Mechanical Thrombectomy

Intervention

Procedure:
• Type of anesthesia choice
Use of conscious sedation vs. general anesthesia

Locations

Country	Name	City	State
Spain	Hospital Universitari Doctor Josep Trueta de Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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

Outcome

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