Ideal Sedation for Stroke Thrombectomy

NCT ID: NCT03036631

Last Updated: 2018-07-19

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

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-04-30

Brief Summary

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The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions whether sedation with intubation and paralytics is feasible and whether it delays the time to recanalization in comparison with conscious sedation alone. As a pilot registry, it is anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18 months. Following enrollment, data will be collected prospectively from medical records and from patients' visits.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Conscious Sedation/Monitored Anesthesia Care

No interventions assigned to this group

General Anesthesia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Suitable for intra-arterial treatment for acute stroke up to 8 hours from onset of symptoms
* Clinical equipoise for best mode of sedation

Exclusion Criteria

* Any known allergy to either proposed medication and its alternative
* Any patient that has been intubated prior to randomization
* Posterior circulation strokes
* Age ≤ 18
* Pregnant female
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. M. Asif Taqi

OTHER

Sponsor Role lead

Responsible Party

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Dr. M. Asif Taqi

Director Neuroendovascular

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Muhammad A Taqi

Role: PRINCIPAL_INVESTIGATOR

Neurovascular Research Foundation

Locations

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Los Robles Hospital and Medical Center

Thousand Oaks, California, United States

Site Status

Countries

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United States

References

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Taqi MA, Suriya SS, Sodhi A, Quadri SA, Farooqui M, Zafar A, Mortazavi MM. Ideal sedation for stroke thrombectomy: a prospective pilot single-center observational study. Neurosurg Focus. 2019 Feb 1;46(2):E16. doi: 10.3171/2018.11.FOCUS18522.

Reference Type DERIVED
PMID: 30717046 (View on PubMed)

Other Identifiers

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20150455

Identifier Type: -

Identifier Source: org_study_id

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