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

Target-controlled Total Intravenous Anesthesia With Propofol Versus Sevoflurane Anesthesia for Endovascular Thrombectomy Procedure in Acute Ischemic Stroke Patients: Comparison of the Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction; General Anesthesia; Ischemic Stroke, Acute; Total Intravenous Anesthesia; Thrombectomy
• Intervention / Treatment: Behavioral: Cognitive function and delirium evaluation; Behavioral: Neurological functional assessment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 298
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Sung Sung, MD, PhD; Phone Number: 320 886-2-28757549; Email: cssung@vghtpe.gov.tw
• Study Contact Backup: Name: Yi-Min Kuo, MD, PhD; Phone Number: 886-9-38593171; Email: arashi881@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Chun-Sung Sung, MD, PhD; Phone Number: 320 886-2-28757549; Email: cssung@vghtpe.gov.tw
    • Contact: Yi-Min Kuo, MD, PhD; Phone Number: 886-9-38593171; Email: arashi881@gmail.com
    • Sub-Investigator: Chun-Jen Lin, MD, PhD
    • Sub-Investigator: Yi-Min Kuo, MD, PhD
    • Principal Investigator: Chun-Sung Sung, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intubated Sevoflurane-GA group; 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.	Behavioral: Cognitive function and delirium evaluation; Cognitive functions (including delirium) will be assessed pre-procedure (baseline) and emergency department (before EVT), on day 1 and 7 and 3 months after EVT procedure; Other Names: Confusion assessment method (CAM); Behavioral: Neurological functional assessment; National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS) will be assessed before (baseline but after stroke) and after EVT on days 1 and 7 after procedure up to 3 months follow-up.; Other Names: National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS)
Active Comparator: Non-intubated TIVA-propofol group; 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.	Behavioral: Cognitive function and delirium evaluation; Cognitive functions (including delirium) will be assessed pre-procedure (baseline) and emergency department (before EVT), on day 1 and 7 and 3 months after EVT procedure; Other Names: Confusion assessment method (CAM); Behavioral: Neurological functional assessment; National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS) will be assessed before (baseline but after stroke) and after EVT on days 1 and 7 after procedure up to 3 months follow-up.; Other Names: National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive function and delirium evaluation	Cognitive functions (including delirium) will be assessed with the confusion assessment method. It is a validated delirium diagnostic tool, and is considered the "gold standard" for detection of delirium.: The four features of delirium are:1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking and 4) altered level of consciousness. A positive diagnosis of delirium is made if the person has feature 1 & 2 plus either 3 or 4. A positive diagnosis of delirium means that the patient's outcome is poor.	Baseline
Change in Cognitive function and delirium evaluation	Cognitive functions (including delirium) will be assessed with the confusion assessment method. It is a validated delirium diagnostic tool, and is considered the "gold standard" for detection of delirium.: The four features of delirium are:1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking and 4) altered level of consciousness. A positive diagnosis of delirium is made if the person has feature 1 & 2 plus either 3 or 4. A positive diagnosis of delirium means that the patient's outcome is poor.	Day 1 after procedure
Change in Cognitive function and delirium evaluation	Cognitive functions (including delirium) will be assessed with the confusion assessment method. It is a validated delirium diagnostic tool, and is considered the "gold standard" for detection of delirium.: The four features of delirium are:1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking and 4) altered level of consciousness. A positive diagnosis of delirium is made if the person has feature 1 & 2 plus either 3 or 4. A positive diagnosis of delirium means that the patient's outcome is poor.	Day 7 after procedure
Change in Cognitive function and delirium evaluation	Cognitive functions (including delirium) will be assessed with the confusion assessment method. It is a validated delirium diagnostic tool, and is considered the "gold standard" for detection of delirium.: The four features of delirium are:1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking and 4) altered level of consciousness. A positive diagnosis of delirium is made if the person has feature 1 & 2 plus either 3 or 4. A positive diagnosis of delirium means that the patient's outcome is poor.	Month 3 after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological function: National Institute of Health Stroke Scale	National Institute of Health Stroke Scale (NIHSS) is widely used as a clinical assessment tool to evaluate acuity of stroke patients, being a predictor of both short and long term outcome of stroke patients, determine appropriate treatment, and predict patient outcome. Scores range from 0 to 42, with higher scores indicating greater severity: score 1-5 as mild, 5-14 as mild to moderately severe, 15-24 as severe, and > 25 as very severe situation.	Baseline
Neurological function: National Institute of Health Stroke Scale	National Institute of Health Stroke Scale (NIHSS) is widely used as a clinical assessment tool to evaluate acuity of stroke patients, being a predictor of both short and long term outcome of stroke patients, determine appropriate treatment, and predict patient outcome. Scores range from 0 to 42, with higher scores indicating greater severity: score 1-5 as mild, 5-14 as mild to moderately severe, 15-24 as severe, and > 25 as very severe situation.	Day 1 after procedure
Neurological function: National Institute of Health Stroke Scale	National Institute of Health Stroke Scale (NIHSS) is widely used as a clinical assessment tool to evaluate acuity of stroke patients, being a predictor of both short and long term outcome of stroke patients, determine appropriate treatment, and predict patient outcome. Scores range from 0 to 42, with higher scores indicating greater severity: score 1-5 as mild, 5-14 as mild to moderately severe, 15-24 as severe, and > 25 as very severe situation.	Day 7 after procedure
Neurological function: National Institute of Health Stroke Scale	National Institute of Health Stroke Scale (NIHSS) is widely used as a clinical assessment tool to evaluate acuity of stroke patients, being a predictor of both short and long term outcome of stroke patients, determine appropriate treatment, and predict patient outcome. Scores range from 0 to 42, with higher scores indicating greater severity: score 1-5 as mild, 5-14 as mild to moderately severe, 15-24 as severe, and > 25 as very severe situation.	Month 3 after procedure
Neurological function: modified Rankin scale	Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0 to 6, with higher scores indicating greater severity: 0: No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	Baseline
Neurological function: modified Rankin scale	Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0 to 6, with higher scores indicating greater severity: 0: No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	Day 1 after procedure
Neurological function: modified Rankin scale	Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0 to 6, with higher scores indicating greater severity: 0: No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	Day 7 after procedure
Neurological function: modified Rankin scale	Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0 to 6, with higher scores indicating greater severity: 0: No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	Month 3 after procedure

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Chair: Hsu Ma, MD, PhD, Institutional Review Board, Taipei Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: general anesthesia; ischemic stroke; postoperative cognitive dysfunction; postoperative delirium; total intravenous anesthesia
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Brain Ischemia; Cognition Disorders; Infarction; Brain Infarction; Stroke; Delirium; Ischemic Stroke; Ischemia; Cognitive Dysfunction; Postoperative Cognitive Complications; Cerebral Infarction
• Other Study ID Numbers: TPEVGH IRB No.: 2021-04-001B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No