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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263117
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Peng Roc Chen, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE August 16, 2017
First Posted Date  ICMJE August 28, 2017
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
modified Rankin Scale (mRS) [ Time Frame: 90 days ]
Independent functional outcome as measured by the percentage of patients with a 0 to 2 on the modified Rankin Scale (mRS) at 90 days assessed by study personnel blinded to treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • 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
  • Rates of recanalization [ Time Frame: post procedure within 6 hours ]
    Rates of recanalization using modified TICI scores
  • National Institute of Health Stroke Scale (NIHSS) scale [ Time Frame: 24-36 hours post procedure ]
    Early clinical improvement measured by difference NIHSS scale
  • modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    Independent functional outcome in General Anesthesia patients treated with inhalational vs. intravenous medications.
  • Quality of life as assessed by the European Quality of Life-5 Dimensions (EQ-5D) instrument [ Time Frame: 90 days ]
  • Incidence of symptomatic intracerebral hemorrhage [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of symptomatic intracerebral hemorrhage
  • Incidence of mortality [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of mortality
  • Incidence of device related complications [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of device related complications
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
  • Incidence of symptomatic intracerebral hemorrhage [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of symptomatic intracerebral hemorrhage
  • Incidence of device related complications [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of device related complications
  • Incidence of mortality [ Time Frame: 18-36 hours post procedure ]
    Safety measured by incidence of mortality
  • Rates of recanalization [ Time Frame: post procedure within 6 hours ]
    Rates of recanalization using modified TICI scores
  • National Institute of Health Stroke Scale (NIHSS) scale [ Time Frame: 24-36 hours post procedure ]
    Early clinical improvement measured by difference NIHSS scale
  • modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    Independent functional outcome in General Anesthesia patients treated with inhalational vs. intravenous medications.
  • Quality of life as assessed by the European Quality of Life-5 Dimensions (EQ-5D) instrument [ Time Frame: 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke
Official Title  ICMJE SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.

  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Sedation
    • Procedure: Intra-arterial Thrombectomy
  • 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.
    Interventions:
    • Drug: General Anesthesia (GA)
    • Procedure: Intra-arterial Thrombectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
260
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2017)
250
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peng Roc Chen, MD 713-486-8016 peng.r.chen@uth.tmc.edu
Contact: Alexander Ambrocik, MS 713-486-7763 alexander.ambrocik@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03263117
Other Study ID Numbers  ICMJE HSC-MS-17-0436
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peng Roc Chen, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Stryker Neurovascular
Investigators  ICMJE
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
Principal Investigator: Sunil Sheth, MD The University of Texas Health Science Center, Houston
Principal Investigator: Sean Savitz, MD The University of Texas Health Science Center, Houston
Principal Investigator: Claudia Pedroza, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP