SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

PHASE4CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

April 22, 2023

Study Completion Date

April 22, 2023

Conditions
Stroke
Interventions
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.

Trial Locations (11)

14617

Rochester Regional Health, Rochester

17822

Geisinger Health, Danville

19122

Temple University, Philadelphia

27157

Wake Forest Baptist Health, Winston-Salem

46202

Indiana University College of Medicine, Indianapolis

48150

Henry Ford Health System, Louisville

52242

University of Iowa Hospitals and Clinics, Iowa City

77024

Memorial Hermann Hospital System - Memorial City Medical Center, Houston

77030

Baylor College of Medicine, Houston

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

77380

Memorial Hermann Hospital System - The Woodlands Medical Center, The Woodlands

All Listed Sponsors
collaborator

Stryker Neurovascular

INDUSTRY

lead

The University of Texas Health Science Center, Houston

OTHER

NCT03263117 - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke | Biotech Hunter | Biotech Hunter