NCT03263117

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-01
• Primary completion: 2023-04-22
• Completion: 2023-04-22
• First posted: 2017-08-28
• Last updated: 2025-11-26
• Results posted: 2024-09-05

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study