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

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493813
• Other study ID #: TPEVGH IRB No.: 2021-04-001B
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chun-Sung Sung, MD, PhD
• Phone: 886-2-28757549
• Email: cssung[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 298
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Cognitive Dysfunction
• Delirium
• General Anesthesia
• Ischemia
• Ischemic Stroke
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Postoperative Delirium
• Stroke
• Thrombectomy
• Total Intravenous Anesthesia

Intervention

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
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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