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

Not yet recruiting

Phase 4 Results N/A

Trial Description

Objectives:
This study aims to assess if the use of general anesthesia (GA) or sedation (CS) in patients with acute stroke undergoing intra-arterial mechanical thrombectomy, leads to better neurological outcomes and less peri-procedural complications.
Hypothesis Null Hypothesis: There are no differences in outcomes in patients with acute stroke treated by intra-arterial mechanical thrombectomy using General anesthesia or Sedation.

Conditions

Interventions

  • Sedation Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sedation
    Description: 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.
  • General Anesthesia (GA) Drug
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: General Anesthesia
    Description: 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.
  • Intra-arterial Thrombectomy Procedure
    Other Names: Endovascular Therapy
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sedation
    Description: 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.
    ARM 2: Kind: Experimental
    Label: General Anesthesia
    Description: 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin Scale (mRS) 90 days
Secondary Incidence of symptomatic intracerebral hemorrhage 18-36 hours post procedure
Secondary Incidence of device related complications 18-36 hours post procedure
Secondary Incidence of mortality 18-36 hours post procedure
Secondary Rates of recanalization post procedure within 6 hours
Secondary National Institute of Health Stroke Scale (NIHSS) scale 24-36 hours post procedure
Secondary Quality of life as assessed by the European Quality of Life-5 Dimensions (EQ-5D) instrument 90 days

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