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Phase 4 N=260 Randomized Single-blind Treatment

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

Stroke

Enrolled (actual)
260
Serious AEs
48.9%
Results posted
Sep 2024
Primary outcome: Primary: Modified Ordinal Rankin Scale (mRS) — 16; 11; 21; 23 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Sedation (Drug); General Anesthesia (GA) (Drug); Intra-arterial Thrombectomy (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The University of Texas Health Science Center, Houston
Primary completion
Apr 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Modified Ordinal Rankin Scale (mRS)
16; 11; 21; 23; 20; 13
SECONDARY
Dichotomized Modified Ordinal Rankin Scale (mRS)
57; 47; 63; 73
SECONDARY
Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b
118; 116
SECONDARY
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)
7; 6
SECONDARY
Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2
57; 47
SECONDARY
Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment
0.47; 0.46
SECONDARY
Number of Participants With Symptomatic Intracerebral Hemorrhage
1; 3
SECONDARY
Number of Participants With All-cause Mortality
11; 9
SECONDARY
Number of Participants With Procedural Complications
4; 5

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

  • 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):
  • Internal Carotid Artery (terminal "T" or "L-type"- occlusion)
  • Middle Cerebral Artery (MCA) M1 or proximal M2
  • 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.
  • Ages 18-90.
  • National Institute of Health Stroke Scale (NIHSS) score 6-30
  • Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
  • Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
  • For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6
  • 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.

  • Subject willing/able to return for protocol required follow up visits.
  • No significant pre-stroke disability (modified Rankin Score must be ≤ 2).
  • Females of childbearing potential must have a negative serum or urine pregnancy test.
  • Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies.

Exclusion Criteria

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

Data sourced from ClinicalTrials.gov (NCT03263117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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