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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Drug: Sedation; Procedure: Intra-arterial Thrombectomy; Drug: General Anesthesia (GA)

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University College of Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 48150
      • Henry Ford Health System
  • New York
    • Rochester, New York, United States, 14617
      • Rochester Regional Health
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77024
      • Memorial Hermann Hospital System - Memorial City Medical Center
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center
    • The Woodlands, Texas, United States, 77380
      • Memorial Hermann Hospital System - The Woodlands Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.	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 Names: Endovascular Therapy; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.); 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	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b	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	post procedure within 6 hours
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)	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	24-36 hours post procedure
Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment	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.	90 days
Number of Participants With Symptomatic Intracerebral Hemorrhage	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.	18-36 hours post procedure
Number of Participants With All-cause Mortality		18-36 hours post procedure
Number of Participants With Procedural Complications		18-36 hours post procedure
Dichotomized Modified Ordinal Rankin Scale (mRS)	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	90 days
Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2	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	90 days

Other Outcome Measures

Outcome Measure	Time Frame
Time From Groin Puncture to Reperfusion	post procedure within 6 hours
Time From Door to TICI ≥ 2b Reperfusion	post procedure within 6 hours

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Stryker Neurovascular
• Investigators: Principal Investigator: Sean Savitz, MD, The University of Texas Health Science Center, Houston; Study Chair: Peng Roc Chen, 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: Claudia Pedroza, PhD, The University of Texas Health Science Center, Houston; Principal Investigator: Andrew Barreto, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.
• 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 Oct 13. doi: 10.1001/jamaneurol.2025.3775. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): April 22, 2023
• Study Completion (Actual): April 22, 2023

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Acute stroke; Cerebral Stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Anesthesia and Analgesia; Anesthesia; Anesthesia, General
• Other Study ID Numbers: HSC-MS-17-0436

Drug and device information, study documents

• 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