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

NCT05493813 | Unknown DMC

• 1 other identifier: TPEVGH IRB No.: 2021-04-001B
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Neurological function: National Institute of Health Stroke Scale

  Baseline

• Neurological function: National Institute of Health Stroke Scale

  Day 1 after procedure

• Neurological function: National Institute of Health Stroke Scale

  Day 7 after procedure

• Neurological function: National Institute of Health Stroke Scale

  Month 3 after procedure

• Neurological function: modified Rankin scale

  Baseline

Study Arms (2)

Intubated Sevoflurane-GA group

ACTIVE COMPARATOR

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; Behavioral: Neurological functional assessment

Non-intubated TIVA-propofol group

ACTIVE COMPARATOR

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; Behavioral: Neurological functional assessment

Interventions

Cognitive function and delirium evaluation BEHAVIORAL

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

Also known as: Confusion assessment method (CAM)

Intubated Sevoflurane-GA group; Non-intubated TIVA-propofol group

Neurological functional assessment BEHAVIORAL

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.

Also known as: National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS)

Intubated Sevoflurane-GA group; Non-intubated TIVA-propofol group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Emergence Delirium; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Study Officials

• Hsu Ma, MD, PhD

  Institutional Review Board, Taipei Veterans General Hospital

  STUDY CHAIR

Central Study Contacts

Chun-Sung Sung, MD, PhD

CONTACT

886-2-28757549; cssung@vghtpe.gov.tw

Yi-Min Kuo, MD, PhD

CONTACT

886-9-38593171; arashi881@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients who meet the enrollment criteria and who provide written informed consent will be randomly assigned to either of the intubated Sev-GA or non-intubated TIVA-propofol groups according to either the discretion of anesthesiologist in charge or random allocation. If the patient was in critical situation, uncooperative, or with uncontrolled movement, the anesthesiologist would choose the intubated Sev-GA instead of the scheduled randomization. However, if patient is cooperative and not critical, the patient would be randomly assigned according to the randomization list created with the use of computer-generated, permuted-block sequences. Only the anesthesiologist and physicians involved in EVT are aware of the anesthesia assignment. On the contrary, patients, personnel who collect data, fill out questionnaire and scale measurement, and personnel who assess outcomes are unaware of the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: August 9, 2022
• Study Start: February 15, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)