Clinical trial NCT05493813: Total Intravenous Anesthesia Versus Sevoflurane Anesthesia for Endovascular Thrombectomy in Acute Ischemic Stroke
Official title: Target-controlled Total Intravenous Anesthesia With Propofol Versus Sevoflurane Anesthesia for Endovascular Thrombectomy Procedure in Acute Ischemic Stroke Patients: Comparison of the Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke, Acute
Thrombectomy
General Anesthesia
Total Intravenous Anesthesia
Postoperative Delirium
Postoperative Cognitive Dysfunction
Keywords: ischemic stroke
general anesthesia
total intravenous anesthesia
postoperative delirium
postoperative cognitive dysfunction
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-08-09
Enrollment: 298
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a prospective, single-centered, double-blind, randomized control trial at Taipei Veterans General Hospital. Patients who are scheduled to undergo emergent EVT for acute ischemic stroke with large vessel occlusion will be randomly assigned to either of the two intra-procedural general anesthetic regimens that include a volatile anesthesia with sevoflurane (Sev-GA) or to a total intravenous anesthesia with propofol (TIVA-propofol).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cognitive function and delirium evaluation
timeFrame: Baseline
measure: Change in Cognitive function and delirium evaluation
timeFrame: Day 1 after procedure
measure: Change in Cognitive function and delirium evaluation
timeFrame: Day 7 after procedure
measure: Change in Cognitive function and delirium evaluation
timeFrame: Month 3 after procedure
Secondary outcomes:
measure: Neurological function: National Institute of Health Stroke Scale
timeFrame: Baseline
measure: Neurological function: National Institute of Health Stroke Scale
timeFrame: Day 1 after procedure
measure: Neurological function: National Institute of Health Stroke Scale
timeFrame: Day 7 after procedure
measure: Neurological function: National Institute of Health Stroke Scale
timeFrame: Month 3 after procedure
measure: Neurological function: modified Rankin scale
timeFrame: Baseline
measure: Neurological function: modified Rankin scale
timeFrame: Day 1 after procedure
measure: Neurological function: modified Rankin scale
timeFrame: Day 7 after procedure
measure: Neurological function: modified Rankin scale
timeFrame: Month 3 after procedure
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Institutional Review Board, Taipei Veterans General Hospital
name: Hsu Ma, MD, PhD
role: STUDY_CHAIR
References: