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

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ClinicalTrials.gov Identifier: NCT03263117
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Peng Roc Chen, 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.


Condition or disease Intervention/treatment Phase
Stroke Drug: Sedation Drug: General Anesthesia (GA) Procedure: Intra-arterial Thrombectomy Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: 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.
Drug: Sedation

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.


Procedure: Intra-arterial Thrombectomy
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 Name: Endovascular Therapy

Active Comparator: General Anesthesia
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.
Drug: General Anesthesia (GA)

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)


Procedure: Intra-arterial Thrombectomy
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 Name: Endovascular Therapy




Primary Outcome Measures :
  1. modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    Comparison of independent clinical outcome as measured by the modified Rankin Scale (mRS) at 90 days (scores 5 and 6 combined) among patients randomized to GA versus Sedation assessed by study personnel blinded to treatment.


Secondary Outcome Measures :
  1. Dichotomized modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    Dichotomized modified Rankin Scale (mRS) at 90 days (0-2 vs 3-6) adjusted for stratification variable

  2. Rates of recanalization [ Time Frame: post procedure within 6 hours ]
    Rates of recanalization using modified TICI scores

  3. National Institute of Health Stroke Scale (NIHSS) scale [ Time Frame: 24-36 hours post procedure ]
    Early clinical improvement measured by difference NIHSS scale

  4. modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    Independent functional outcome in General Anesthesia patients treated with inhalational vs. intravenous medications.

  5. Quality of life as assessed by the European Quality of Life-5 Dimensions (EQ-5D) instrument [ Time Frame: 90 days ]
  6. Incidence of symptomatic intracerebral hemorrhage [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of symptomatic intracerebral hemorrhage

  7. Incidence of mortality [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of mortality

  8. Incidence of device related complications [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of device related complications



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or Cervical Carotid 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 18-80.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263117


Contacts
Contact: Peng Roc Chen, MD 713-704-7100 peng.r.chen@uth.tmc.edu
Contact: Aditya Sanzgiri, MBBS, MPH 713-704-7263 aditya.a.sanzgiri@uth.tmc.edu

Locations
United States, Texas
McGovern Medical School part of UT Health Recruiting
Houston, Texas, United States, 77030
Contact: Sunil Sheth, MD    713-500-7897    sunil.a.sheth@uth.tmc.edu   
Contact: Aditya Sanzgiri, MBBS MPH    713-704-7263    Aditya.A.Sanzgiri@uth.tmc.edu   
Principal Investigator: Sunil A Sheth, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Stryker Neurovascular
Investigators
Study Chair: Peng Roc Chen, MD The University of Texas Health Science Center, Houston
Principal Investigator: Andrew Barreto, MD The University of Texas Health Science Center, Houston
Principal Investigator: Carlos Artime, MD The University of Texas Health Science Center, Houston

Responsible Party: Peng Roc Chen, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03263117     History of Changes
Other Study ID Numbers: HSC-MS-17-0436
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Peng Roc Chen, The University of Texas Health Science Center, Houston:
Acute stroke
Cerebral Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs