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Completed

NCT Number: NCT05082896

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

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.

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Key information

Conditions

Mechanical Thrombectomy Conscious Sedation General Anesthesia Posterior Circulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Doctor Josep Trueta de Girona

Girona, 17007, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type of anesthesia choice

Procedure

Use of conscious sedation vs. general anesthesia

Primary outcomes

  1. Functional independence at 3 months

    Time frame: 3 months

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

Secondary outcomes

  1. First Pass Effect

    Time frame: 1 day

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

  2. Mortality

    Time frame: 3 months

    Rate of mortality at 3 months

  3. Successfull recanalization and complete recanalization according to endovascular technique

    Time frame: 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

    Time frame: 1 day, number of device passes will be assessed

    Number of intracranial thrombectomy passes to achieve final reperfusion

  5. NIHSS at 24 hours

    Time frame: 24 hours

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

  6. Type of anesthesic and outcome

    Time frame: 3 months

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

  7. Length of stentretriever and recanalization

    Time frame: 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

    Time frame: 3 months

    Study of arterial hypotension during anesthesic induction and outcome

  9. Bridging therapy and neurologial/functional outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2021
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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