SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: Sedation; Drug: General Anesthesia (GA); Procedure: Intra-arterial Thrombectomy

• Registration Number: NCT03263117
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-28
• Study Start: 2018-07-01
• Status Verified: 2023-03
• Primary Completion: 2023-04-22
• Study Completion: 2023-04-22
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia	Intra-arterial Thrombectomy	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.
Sedation	Sedation	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.
Sedation	Intra-arterial Thrombectomy	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.
General Anesthesia	General Anesthesia (GA)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Score of 5 or 6 on the Modified Rankin Scale (mRS)	90 days	The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence.; * 0: no symptoms/normal (physical, cognitive etc.); * 1: no significant disability despite symptoms; able to carry out all usual duties and activities; * 2: slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; * 3: moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance); * 4: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; * 5: severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6: dead

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2	90 days	The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence.; * 0: no symptoms/normal (physical, cognitive etc.); * 1: no significant disability despite symptoms; able to carry out all usual duties and activities; * 2: slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; * 3: moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance); * 4: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; * 5: severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6: dead
Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b	post procedure within 6 hours	The thrombolysis in cerebral infarction (TICI) grading system is a tool for determining the response of thrombolytic therapy for ischemic stroke. The TICI grade ranges from 0 to 3, with a higher score indicating greater perfusion.; grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)	24-36 hours post procedure	The National Institutes of Health Stroke Scale (NIHSS) is a tool used objectively quantify the impairment caused by a stroke. Total score ranges from 0 - 42, with a higher score indicating greater severity of impairment caused by stroke.; 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Score on mRS	90 days	The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence.; * 0: no symptoms/normal (physical, cognitive etc.); * 1: no significant disability despite symptoms; able to carry out all usual duties and activities; * 2: slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; * 3: moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance); * 4: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; * 5: severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6: dead
Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment	90 days	The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Number of Participants With Symptomatic Intracerebral Hemorrhage	18-36 hours post procedure	Symptomatic intracerebral hemorrhage was defined using the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition, a ≥ 4 point increase in NIHSS score with a parenchymal hemorrhage type 2 within 36 hours.
Number of Participants With All-cause Mortality	18-36 hours post procedure
Number of Participants With Procedural Complications	18-36 hours post procedure

Trial Locations

Locations (11)

Geisinger Health; 🇺🇸 Danville, Pennsylvania, United States

University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center; 🇺🇸 Houston, Texas, United States

Memorial Hermann Hospital System - The Woodlands Medical Center; 🇺🇸 The Woodlands, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Rochester Regional Health; 🇺🇸 Rochester, New York, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Memorial Hermann Hospital System - Memorial City Medical Center; 🇺🇸 Houston, Texas, United States

Indiana University College of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Henry Ford Health System; 🇺🇸 Louisville, Kentucky, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States