Total Intravenous Anesthesia Versus Sevoflurane Anesthesia for Endovascular Thrombectomy in Acute Ischemic Stroke

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Thrombectomy; Total Intravenous Anesthesia; General Anesthesia; Ischemic Stroke, Acute; Postoperative Delirium; Postoperative Cognitive Dysfunction

Treatments: Behavioral: Neurological functional assessment; Behavioral: Cognitive function and delirium evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05493813

TPEVGH IRB No.: 2021-04-001B

Details and patient eligibility

About

The present clinical trial compares the effect of two general anesthesia (GA) modalities, the one with volatile anesthetic sevoflurane (endotracheal-intubated) and the other integrating total intravenous anesthesia (TIVA) with propofol (non-intubated), on post-procedural delirium and cognitive dysfunction after endovascular thrombectomy (EVT) in the participants with acute ischemic stroke. To assess the outcome of both modalities, the sedation depth of GA will be regulated with processed electroencephalogram monitor to reduce the incidence of postoperative delirium and the peri-procedural blood pressure will be controlled according to the guideline.Based on that, the investigators try to find a better general anesthetic modality for acute ischemic stroke participants undergoing EVT.

Full description

1. In 2019, cerebrovascular disease (i.e., stroke) was the second leading cause of death worldwide.
2. The present guidelines for the early management of the participants with acute ischemic stroke urge the in-time and early application of intravenous chemical thrombolysis and endovascular thrombectomy (EVT) due to better outcome and prognosis. "Timing is brain."
3. The participants with acute ischemic stroke, previous stroke, and severe stroke have high incidence of delirium, and the stroke-related delirium has been shown to correlate with higher morbidity and mortality.
4. Researches on the anesthetic management during EVT for acute ischemic stroke have shown that both general anesthesia and sedation anesthesia are safe and without difference in neurological outcome and long-term complications. However, general anesthesia might have higher rates in revascularization in EVT for acute ischemic stroke as compared with sedation anesthesia.
5. Anesthesia could produce postoperative cognitive dysfunction (POCD) or delirium (POD), and general anesthesia could produce higher rates of POCD and POD compared to general anesthesia and sedation anesthesia. Additionally, brain injury and acute ischemic stroke are independent risk factors for POCD and POD. Whether the anesthetic management for EVT would interfere with the acute ischemic stroke-produced POCD and/or POD or even delay the detection and treatment of stroke-related neurological impairment deserves investigation since EVT is the gold standard for acute ischemic stroke.

Enrollment: 298 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of acute ischemic stroke with large vessel occlusion who are scheduled to undergo endovascular thrombectomy procedure, and
• Must be age of 20 to 90
• Must fulfill the indications for endovascular thrombectomy in acute ischemic stroke according to the American Heart Association/American Stroke Association 2018 Guidelines for the early management of patients with acute ischemic stroke and 2019 Taiwan stroke society guideline for endovascular thrombectomy in acute ischemic stroke, and
• Must agree to enroll into the clinical trial and sign the written informed consent from patients or delegates

Exclusion criteria

• Allergy to allergy to the anesthetics used in this clinical study
• Refusal for enrolling in study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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298 participants in 2 patient groups

Intubated Sevoflurane-GA group

Active Comparator group

Description:

After preoxygenation for 3 minutes with 100% oxygen, anesthesia is induced with intravenous injection of propofol (1.5-2 mg/kg), remifentanil infusion (Ce value around 1-1.5 ng/kg), and cisatracurium (0.15-0.2 mg/kg), and followed by endotracheal intubation. General anesthesia is maintained with cisatracuirum (0.03 mg/kg every 45-50 min), remifentanil (Ce value around 1-1.5 ng/kg) and sevoflurane inhalation. Sevoflurane concentration will be adjusted to keep BIS value within the range of 40-60. Mechanical ventilation will be processed at volume-controlled mode with fraction of inspired oxygen (FiO2) 60%, tidal volume 6 ml/kg, and respiratory rate 9-12/min to keep normocapnia and avoid desaturation during the EVT procedure.

Treatment:

Behavioral: Cognitive function and delirium evaluation

Behavioral: Neurological functional assessment

Non-intubated TIVA-propofol group

Active Comparator group

Description:

With the application of Optiflow nasal high flow set at a flow rate of 20 L/min and 60% FiO2, total intravenous anesthesia is induced with target-controlled infusion of propofol (effect site (Ce) concentration around 1.5-2 μg/ml) and remifentanil (Ce value around 1.0-1.5 ng/ml), and adjusted as required.

Treatment:

Behavioral: Cognitive function and delirium evaluation

Behavioral: Neurological functional assessment