Clinical trial NCT03263117: SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke
Official title: SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: Acute stroke
Cerebral Stroke
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Stryker Neurovascular
First posted: 2017-08-28
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives:

This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life.

Hypothesis:

GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.


Eligibility criteria: Inclusion Criteria:

1. Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT):

   1. Internal Carotid Artery (terminal "T" or "L-type"- occlusion)
   2. Middle Cerebral Artery (MCA) M1 or proximal M2
   3. Anterior Cerebral Artery (ACA) A1 or proximal A2

      * Patients who receive IV-tPA thrombolysis are eligible provided the drug was delivered within 4.5 hours of stroke onset or last seen normal and in accordance with local hospital standard of care.
2. Ages 18-90.
3. National Institute of Health Stroke Scale (NIHSS) score 6-30
4. Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
5. Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines

   1. For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6
   2. For patients presenting \> 6 hours and ≤ 16 hours from time of symptom onset or last seen normal, they must satisfy EITHER ONE of the two following criteria:

   i. Ischemic core by CT Perfusion or MRI/MR Perfusion \< 70 mL, a ratio of volume of penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of \< 31 mL by CT Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core \< 51 mL.
6. Subject willing/able to return for protocol required follow up visits.
7. No significant pre-stroke disability (modified Rankin Score must be ≤ 2).
8. Females of childbearing potential must have a negative serum or urine pregnancy test.
9. Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies.

Exclusion Criteria:

1. Coma on admission (Glasgow Coma Scale \<8), need for intubation upon ED arrival, or transferred patients who present previously intubated.
2. Severe agitation or seizures on admission that preclude safe vascular access.
3. Loss of airway protective reflexes and/or vomiting on admission.
4. Predicted or known difficult airway.
5. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia.
6. Presumed septic embolus, or suspicion of bacterial endocarditis
7. Currently participating or has participated in any investigational drug or device study within 30 days.
8. Inability to follow-up for 90-day assessment.
9. Known history of allergy to anesthesia drugs.
10. Known history or family history of malignant hyperthermia

Primary outcomes:
measure: Number of Participants With a Score of 5 or 6 on the Modified Rankin Scale (mRS)
timeFrame: 90 days
Secondary outcomes:
measure: Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2
timeFrame: 90 days
measure: Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b
timeFrame: post procedure within 6 hours
measure: Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)
timeFrame: 24-36 hours post procedure
measure: Score on mRS
timeFrame: 90 days
measure: Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment
timeFrame: 90 days
measure: Number of Participants With Symptomatic Intracerebral Hemorrhage
timeFrame: 18-36 hours post procedure
measure: Number of Participants With All-cause Mortality
timeFrame: 18-36 hours post procedure
measure: Number of Participants With Procedural Complications
timeFrame: 18-36 hours post procedure
Other outcomes:
measure: Time From Groin Puncture to Reperfusion
timeFrame: post procedure within 6 hours
measure: Time From Door to TICI ≥ 2b Reperfusion
timeFrame: post procedure within 6 hours
Locations:
city: Indianapolis
country: United States
facility: Indiana University College of Medicine
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Henry Ford Health System
state: Kentucky
city: Rochester
country: United States
facility: Rochester Regional Health
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Danville
country: United States
facility: Geisinger Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Hermann Hospital System - Memorial City Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center
state: Texas
city: The Woodlands
country: United States
facility: Memorial Hermann Hospital System - The Woodlands Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Peng Roc Chen, MD
role: STUDY_CHAIR
affiliation: The University of Texas Health Science Center, Houston
name: Andrew Barreto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Carlos Artime, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Sunil Sheth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Sean Savitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Claudia Pedroza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.