SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke (SEGA)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Stroke

Treatments: Drug: General Anesthesia (GA); Drug: Sedation; Procedure: Intra-arterial Thrombectomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03263117

HSC-MS-17-0436

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Sedation

Active Comparator group

Description:

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.

Treatment:

Procedure: Intra-arterial Thrombectomy

Drug: Sedation

General Anesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Intra-arterial Thrombectomy

Drug: General Anesthesia (GA)