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Sedation for Stroke (SEGA Trial)

Phase 4

Waitlist Available

Led By Andrew Barreto, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-36 hours post procedure

Awards & highlights

SEGA Trial Summary

This trial will compare the effects of General Anesthesia and Sedation during endovascular therapy for acute ischemic stroke patients. The primary outcome is functional disability at 90 days.

Eligible Conditions

Stroke

SEGA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-36 hours post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-36 hours post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-36 hours post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Dichotomized modified Rankin Scale (mRS)

Incidence of device related complications

Incidence of mortality

+5 more

SEGA Trial Design

2Treatment groups

Active Control

Group I: SedationActive Control2 Interventions

The protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist.

Group II: General AnesthesiaActive Control2 Interventions

The protocol does not specify a particular combination of drugs that must be used for general anesthesia. The choice of specific drugs and dosages for achieving general anesthesia will be up to the anesthesiologist.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,764 Total Patients Enrolled

42 Trials studying Stroke

7,147 Patients Enrolled for Stroke

Stryker NeurovascularIndustry Sponsor

34 Previous Clinical Trials

11,979 Total Patients Enrolled

10 Trials studying Stroke

3,822 Patients Enrolled for Stroke

Andrew Barreto, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

1 Previous Clinical Trials

90 Total Patients Enrolled

1 Trials studying Stroke

90 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people outside of the elderly demographic eligible to participate in this trial?

"To be eligible for participation, patients must be 18 years or older and no more than 90."

Answered by AI

How many individuals are participating in this research project?

"The medical research requires 260 participants to meet the entry criteria, who can be recruited from two locations: Memorial Hermann Hospital System - Memorial City Medical Center in Houston and Baylor College of Medicine in Indianapolis."

Answered by AI

Is recruitment underway for this medical research project?

"This clinical trial is open for enrollment, with a first posting date of July 1st 2018 and the latest update occurring on October 15th 2021. This information can be found on clinicaltrials.gov."

Answered by AI

Has the FDA granted approval to utilize sedation in medical treatments?

"The safety of Sedation is rated at 3, since it has progressed to Phase 4 clinical trials and received its regulatory approval."

Answered by AI

For whom is participation in this clinical study permissible?

"This medical trial requires 260 participants aged between 18 and 90 that have recently suffered a stroke. In addition to this, patients may only be admitted if they meet the following criteria: The time of onset must not exceed 16 hours; an ASPECTS score of 6 or higher is obligatory for those presenting ≤6 hours after symptom commencement; evidence of internal carotid artery occlusion needs to be present; IV-tPA thrombolysis, if received, must fall within 4.5 hours from the start of symptoms or last seen normal status in accordance with local hospital protocol; NIHSS scores should be located between 6-30"

Answered by AI

How many locations are actively participating in this research endeavor?

"Memorial Hermann Hospital System - Memorial City Medical Center in Houston, Texas, Baylor College of Medicine in Indianapolis, Indiana and Indiana University College of Medicine in Iowa City, Iowa are some centres trialling this medication. There are also 11 other sites around the United States."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

Peng Roc Chen, MD 2018. "SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03263117.