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Completed

NCT Number: NCT03263117

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University College of Medicine, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation

Drug

The protocol does not specify a particular combination of drugs that must be used for sedation.

The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.

General Anesthesia (GA)

Drug

The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.

The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed)

intra-arterial thrombectomy

Procedure

The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team.

Other names: Endovascular Therapy

Primary outcomes

  1. Modified Ordinal Rankin Scale (mRS)

    Time frame: 90 days

    mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category.

    0: no symptoms/normal (physical, cognitive etc.)

    • no significant disability despite symptoms; able to carry out all usual duties and activities
    • slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance)
    • moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • dead

Secondary outcomes

  1. Dichotomized Modified Ordinal Rankin Scale (mRS)

    Time frame: 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. 2 categories are reported: number of participants who had a score of 0-2, and number who had a score of 3-6.

    0: no symptoms/normal (physical, cognitive etc.)

    • no significant disability despite symptoms; able to carry out all usual duties and activities
    • slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance)
    • moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • dead

  2. Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b

    Time frame: 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

  3. Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)

    Time frame: 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

  4. Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2

    Time frame: 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.)

    • no significant disability despite symptoms; able to carry out all usual duties and activities
    • slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance)
    • moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • dead

  5. Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment

    Time frame: 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.

  6. Number of Participants With Symptomatic Intracerebral Hemorrhage

    Time frame: 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.

  7. Number of Participants With All-cause Mortality

    Time frame: 18-36 hours post procedure

  8. Number of Participants With Procedural Complications

    Time frame: 18-36 hours post procedure

Other outcomes

  1. Time From Groin Puncture to Reperfusion

    Time frame: post procedure within 6 hours

  2. Time From Door to TICI ≥ 2b Reperfusion

    Time frame: post procedure within 6 hours

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Stryker Neurovascular

Registry information

Official study title

SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.

Acronym: SEGA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2017
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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