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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05082896
Other study ID # MORPHEUS STROKE REGISTRY
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
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

Study Design


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 allClick 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
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