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

March 7, 2024 updated by: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

453

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Girona, Spain, 17007
        • Hospital Universitari Doctor Josep Trueta de Girona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General Anesthesia
Procedure: Type of anesthesia choice
Use of conscious sedation vs. general anesthesia
Conscious Sedation
Procedure: Type of anesthesia choice
Use of conscious sedation vs. general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional independence at 3 months
Time Frame: 3 months
Rate of functional independence (modified Rankin Scale 0-2) at 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Pass Effect
Time Frame: 1 day
Rate of complete successful recanalization (mTICI 2c-3) with one single pass of device
1 day
Mortality
Time Frame: 3 months
Rate of mortality at 3 months
3 months
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)
1 day, revascularization grade will be assessed
Number of passes
Time Frame: 1 day, number of device passes will be assessed
Number of intracranial thrombectomy passes to achieve final reperfusion
1 day, number of device passes will be assessed
NIHSS at 24 hours
Time Frame: 24 hours
Rate of neurological status at 24 hours, dramatical neurological improvement after mechanical thrombectomy
24 hours
Type of anesthesic and outcome
Time Frame: 3 months
Study of the type of anesthesic choice and complications, time of intubation and
3 months
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
1 day, stentretriever type will be assessed
Arterial hypotension during anesthesic induction and outcome
Time Frame: 3 months
Study of arterial hypotension during anesthesic induction and outcome
3 months
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.
1 day, type of previous fibrinolytic use will be assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MORPHEUS STROKE REGISTRY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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