SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

NCT03263117 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: HSC-MS-17-0436
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 11

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.

Conditions

Stroke

Keywords

Acute stroke; Cerebral Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Ordinal Rankin Scale (mRS)

  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.) 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

  90 days

Secondary Outcomes (8)

• Dichotomized Modified Ordinal Rankin Scale (mRS)

  90 days

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

  post procedure within 6 hours

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

  24-36 hours post procedure

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

  90 days

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

  90 days

Other Outcomes (2)

• Time From Groin Puncture to Reperfusion

  post procedure within 6 hours

• Time From Door to TICI ≥ 2b Reperfusion

  post procedure within 6 hours

Study Arms (2)

Sedation

ACTIVE COMPARATOR

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; Procedure: Intra-arterial Thrombectomy

General Anesthesia

ACTIVE COMPARATOR

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); Procedure: Intra-arterial Thrombectomy

Interventions

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.

Sedation

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)

General Anesthesia

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.

Also known as: Endovascular Therapy

General Anesthesia; Sedation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Stryker Neurovascular: collaborator

Study Sites (11)

Indiana University College of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Henry Ford Health System

Louisville, Kentucky, 48150, United States

Location

Rochester Regional Health

Rochester, New York, 14617, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Geisinger Health

Danville, Pennsylvania, 17822, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Memorial Hermann Hospital System - Memorial City Medical Center

Houston, Texas, 77024, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital System - The Woodlands Medical Center

The Woodlands, Texas, 77380, United States

Location

Related Publications (2)

• Chen PR, Artime CA, Sheth SA, Pedroza C, Ortega-Gutierrez S, Wolfe S, Sitton C, Kan P, Tanweer O, Chebl A, Schirmer CM, Morrow JT, Alderazi YJ, Bohnstedt B, Erkmen K, Samaniego EA, Garrido E, Savitz SI, Engstrom A, Aguilar E, Nguyen T, Barreto AD; SEGA Investigators. Sedation vs General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke: The SEGA Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1265-1273. doi: 10.1001/jamaneurol.2025.3775.

  PMID: 41082222 DERIVED

• Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.

  PMID: 35857365 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Peng Roc Chen, MD
• Organization: The University of Texas Health Science Center at Houston

peng.r.chen@uth.tmc.edu

713-486-8016

Study Officials

• Peng Roc Chen, MD

  The University of Texas Health Science Center, Houston

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Neurosurgery

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 28, 2017
• Study Start: July 1, 2018
• Primary Completion: April 22, 2023
• Study Completion: April 22, 2023
• Last Updated: November 26, 2025
• Results First Posted: September 5, 2024

Record last verified: 2025-09

Locations

US (11)