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

Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other)
Overall Status
Recruiting
CT.gov ID
NCT05082896
Collaborator
(none)
174
1
20.9
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Type of anesthesia choice

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
174 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Multicentre ObseRvational Study in Posterior mecHanical thrombEctomy: conscioUs Sedation vs General aneSthesia: MORPHEUS STROKE REGISTRY
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Conscious Sedation

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

General Anesthesia

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

Outcome Measures

Primary Outcome Measures

  1. Functional independence at 3 months [3 months]

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

Secondary Outcome Measures

  1. First Pass Effect [1 day]

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

  2. Mortality [3 months]

    Rate of mortality at 3 months

  3. 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)

  4. Number of passes [1 day, number of device passes will be assessed]

    Number of intracranial thrombectomy passes to achieve final reperfusion

  5. NIHSS at 24 hours [24 hours]

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

  6. Type of anesthesic and outcome [3 months]

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

  7. 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

  8. Arterial hypotension during anesthesic induction and outcome [3 months]

    Study of arterial hypotension during anesthesic induction and outcome

  9. 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 Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitari Doctor Josep Trueta de Girona Girona Spain 17007

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier:
NCT05082896
Other Study ID Numbers:
  • MORPHEUS STROKE REGISTRY
First Posted:
Oct 19, 2021
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021