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Mechanical ThrombectomyNCT05082896

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

An observational study of Mechanical Thrombectomy and General Anesthesia, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Type of anesthesia choice
Type of treatment
Surgery or procedure
How many people
453 participants
Where
1 siteSpain
Study dates
1 Jan 2021to 30 Jun 2023
How long will I take part?
18 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitari Doctor Josep Trueta de Girona

    Girona, 17007

Other trials in Spain

About this study

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.

Being tested
Type of anesthesia choice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Type of anesthesia choiceProcedure or surgery

    Use of conscious sedation vs. general anesthesia

Study groups in NCT05082896
Study groupRoleWhat they receive
Conscious SedationNot described
Receives: Procedure: Type of anesthesia choice
General AnesthesiaNot described
Receives: Procedure: Type of anesthesia choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional independence at 3 months

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

    Measured: 3 months

Secondary outcomes (9)
  1. First Pass Effect

    Rate of complete successful recanalization (mTICI 2c-3) with one single pass of device

    Measured: 1 day

  2. Mortality

    Rate of mortality at 3 months

    Measured: 3 months

  3. 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)

    Measured: 1 day, revascularization grade will be assessed

  4. Number of passes

    Number of intracranial thrombectomy passes to achieve final reperfusion

    Measured: 1 day, number of device passes will be assessed

  5. NIHSS at 24 hours

    Rate of neurological status at 24 hours, dramatical neurological improvement after mechanical thrombectomy

    Measured: 24 hours

  6. Type of anesthesic and outcome

    Study of the type of anesthesic choice and complications, time of intubation and

    Measured: 3 months

  7. Length of stentretriever and recanalization

    Rates of FPE and succesful recanalization according to the length of stentretriever used

    Measured: 1 day, stentretriever type will be assessed

  8. Arterial hypotension during anesthesic induction and outcome

    Study of arterial hypotension during anesthesic induction and outcome

    Measured: 3 months

  9. Bridging therapy and neurologial/functional outcomes

    To study the association between bridging therapy and reperfussion rates, neurological status and funtional independence at 3 months.

    Measured: 1 day, type of previous fibrinolytic use will be assessed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start1 Jan 2021
  3. Primary completion30 Mar 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
453 participants (actual)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05082896
Sponsor's protocol ID
MORPHEUS STROKE REGISTRY
Status last verified
Mar 2024
First submitted
13 Sep 2021
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 33841679
  • 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.

    PubMed 32717535
  • 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.

    PubMed 28395002
  • 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.

    PubMed 29263006
  • 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.

    PubMed 29089457
  • 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.

    PubMed 33573525
  • 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.

    PubMed 29393092
  • 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.

    PubMed 31573636
  • 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.

    PubMed 32517584
  • 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.

    PubMed 33758063
  • 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.

    PubMed 28904228

Questions about this trial

What is this clinical trial studying?

An observational study of Mechanical Thrombectomy and General Anesthesia, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional independence at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05082896, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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