SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

Stroke Clinical Trial

— SEGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263117
• Other study ID #: HSC-MS-17-0436
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: April 22, 2023

Study information

• Verified date: March 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 22, 2023
• Est. primary completion date: April 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Geisinger Health	Danville	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	Memorial Hermann Hospital System - Memorial City Medical Center	Houston	Texas
United States	University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center	Houston	Texas
United States	Indiana University College of Medicine	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Henry Ford Health System	Louisville	Kentucky
United States	Temple University	Philadelphia	Pennsylvania
United States	Rochester Regional Health	Rochester	New York
United States	Memorial Hermann Hospital System - The Woodlands Medical Center	The Woodlands	Texas
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Stryker Neurovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale (mRS)	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.	90 days
Secondary	Dichotomized modified Rankin Scale (mRS)	Dichotomized modified Rankin Scale (mRS) at 90 days (0-2 vs 3-6) adjusted for stratification variable	90 days
Secondary	Rates of recanalization	Rates of recanalization using modified TICI scores	post procedure within 6 hours
Secondary	National Institute of Health Stroke Scale (NIHSS) scale	Early clinical improvement measured by difference NIHSS scale	24-36 hours post procedure
Secondary	modified Rankin Scale (mRS)	Independent functional outcome in General Anesthesia patients treated with inhalational vs. intravenous medications.	90 days
Secondary	Quality of life as assessed by the European Quality of Life-5 Dimensions (EQ-5D) instrument		90 days
Secondary	Incidence of symptomatic intracerebral hemorrhage	Safety measured by incidence of symptomatic intracerebral hemorrhage	18-36 hours post procedure
Secondary	Incidence of mortality	Safety measured by incidence of mortality	18-36 hours post procedure
Secondary	Incidence of device related complications	Safety measured by incidence of device related complications	18-36 hours post procedure