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

Completed

• Conditions: Mechanical Thrombectomy; General Anesthesia; Conscious Sedation; Posterior Circulation
• Interventions: Procedure: Type of anesthesia choice

• Registration Number: NCT05082896
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-19
• Primary Completion: 2023-03-30
• Study Completion: 2023-06-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 453

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General Anesthesia	Type of anesthesia choice	-
Conscious Sedation	Type of anesthesia choice	-

Primary Outcome Measures

Name	Time	Method
Functional independence at 3 months	3 months	Rate of functional independence (modified Rankin Scale 0-2) at 3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitari Doctor Josep Trueta de Girona; 🇪🇸 Girona, Spain