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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03263117
• Collaborator: Stryker Neurovascular (Industry)
• Enrollment: 260
• Locations: 12
• Arms: 2
• Anticipated Duration (Months): 56
• Patients Per Site: 21.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2018
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

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.	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 Names: Endovascular Therapy

Outcome Measures

Primary Outcome Measures

1. modified Rankin Scale (mRS) [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) [90 days]

   Dichotomized modified Rankin Scale (mRS) at 90 days (0-2 vs 3-6) adjusted for stratification variable

2. Rates of recanalization [post procedure within 6 hours]

   Rates of recanalization using modified TICI scores

3. National Institute of Health Stroke Scale (NIHSS) scale [24-36 hours post procedure]

   Early clinical improvement measured by difference NIHSS scale

4. modified Rankin Scale (mRS) [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 [90 days]

6. Incidence of symptomatic intracerebral hemorrhage [18-36 hours post procedure]

   Safety measured by incidence of symptomatic intracerebral hemorrhage

7. Incidence of mortality [18-36 hours post procedure]

   Safety measured by incidence of mortality

8. Incidence of device related complications [18-36 hours post procedure]

   Safety measured by incidence of device related complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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):

2. Internal Carotid Artery (terminal "T" or "L-type"- occlusion)

3. Middle Cerebral Artery (MCA) M1 or proximal M2

4. 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.

1. Ages 18-90.

2. National Institute of Health Stroke Scale (NIHSS) score 6-30

3. Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.

4. Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines

5. For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6

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:

1. 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.

1. Subject willing/able to return for protocol required follow up visits.

2. No significant pre-stroke disability (modified Rankin Score must be ≤ 2).

3. Females of childbearing potential must have a negative serum or urine pregnancy test.

4. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University College of Medicine	Indianapolis	Indiana	United States	46202
2	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
3	Henry Ford Health System	Louisville	Kentucky	United States	48150
4	Rochester Regional Health	Rochester	New York	United States	14617
5	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
6	Oklahoma University Health Science Center	Oklahoma City	Oklahoma	United States	73104
7	Geisinger Health	Danville	Pennsylvania	United States	17822
8	Temple University	Philadelphia	Pennsylvania	United States	19122
9	Memorial Hermann Hospital System - Memorial City Medical Center	Houston	Texas	United States	77024
10	Baylor College of Medicine	Houston	Texas	United States	77030
11	University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center	Houston	Texas	United States	77030
12	Memorial Hermann Hospital System - The Woodlands Medical Center	The Woodlands	Texas	United States	77380

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
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peng Roc Chen, Professor in Neurosurgery, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03263117
• Other Study ID Numbers: HSC-MS-17-0436
• First Posted: Aug 28, 2017
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

• 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, Professor in Neurosurgery, The University of Texas Health Science Center, Houston: Acute stroke; Cerebral Stroke
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Anesthetics

Study Results

No Results Posted as of Oct 22, 2021