Risk Factors of Conversion From Local to General Sedation in Endovascular Stroke Therapy

NCT ID: NCT02895776

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-22

Study Completion Date

2017-01-31

Brief Summary

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Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data tend to show that final neurologic outcome is superior if the thrombectomy procedure was performed under conscious sedation.

The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures every year.

We report a rate of 5% of these procedures requiring general anesthesia despite conscious sedation being the standard of care. This study aims to identify clinical factors associated with a risk of conversion of a conscious sedation to a general anesthesia.

Detailed Description

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Conditions

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Acute Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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General Sedation

Case patients: Endovascular Acute Stroke Therapy scheduled to be performed under local sedation and finally performed under General anesthesia

No interventions assigned to this group

local sedation

Control patients: Endovascular Acute Stroke Therapy scheduled to be performed, and actually performed under conscious Sedation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients undergoing thrombectomy for ischemic stroke
* age ≥ 18 years old

Exclusion Criteria

* patient already under general anesthesia
* general sedation required
* haemorrhagic softening diagnosed before the beginning of procedure
* patient refusal to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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GTR_2015_23

Identifier Type: -

Identifier Source: org_study_id

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