Ischemic Stroke, AcuteNCT05493813
Total Intravenous Anesthesia Versus Sevoflurane Anesthesia for Endovascular Thrombectomy in Acute Ischemic Stroke
A study testing Cognitive function and delirium evaluation and Neurological functional assessment in people with Ischemic Stroke, Acute and Thrombectomy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Ischemic Stroke, Acute, Thrombectomy, General Anesthesia
- What is being tested?
- Cognitive function and delirium evaluation and Neurological functional assessment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergy to allergy to the anesthetics used in this clinical study
- Refusal for enrolling in study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Chun-Sung Sung, MD, PhD, 886-2-28757549 ext. 320, cssung@vghtpe.gov.tw
Yi-Min Kuo, MD, PhD, 886-9-38593171, arashi881@gmail.com
About this study
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
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.
Read the detailed description
- In 2019, cerebrovascular disease (i.e., stroke) was the second leading cause of death worldwide.
- 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."
- 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.
- 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.
- 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.
- Conditions
- Ischemic Stroke, Acute, Thrombectomy, General Anesthesia, Total Intravenous Anesthesia, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Being tested
- Cognitive function and delirium evaluation, Neurological functional assessment
- Keywords
- ischemic stroke, general anesthesia, total intravenous anesthesia, postoperative delirium, postoperative cognitive dysfunction
- Medical subject headings
- Ischemic Stroke, Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive function and delirium evaluationBehavioural
Also called Confusion assessment method (CAM)
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 assessmentBehavioural
Also called National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive function and delirium evaluation; Behavioral: Neurological functional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 3 after procedure
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 3 after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start15 Feb 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hsu Ma, MD, PhD, Study chair, Institutional Review Board, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493813
- Sponsor's protocol ID
- TPEVGH IRB No.: 2021-04-001B
- Status last verified
- Feb 2023
- First submitted
- 23 May 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05493813
- Acronym / sponsor ID
- TPEVGH IRB No.: 2021-04-001B
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- In 2019, cerebrovascular disease (i.e., stroke) was the second leading cause of death worldwide.
- 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."
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intubated Sevoflurane-GA group | Active comparator | Behavioral: Cognitive function and delirium evaluation, Behavioral: Neurological functional assessmentAfter 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. |
| Non-intubated TIVA-propofol group | Active comparator | Behavioral: Cognitive function and delirium evaluation, Behavioral: Neurological functional assessmentWith 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Allergy to allergy to the anesthetics used in this clinical study
- Refusal for enrolling in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive function and delirium evaluationAlso: Confusion assessment method (CAM)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 | Behavioural | Intubated Sevoflurane-GA group, Non-intubated TIVA-propofol group |
| Neurological functional assessmentAlso: National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS)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. | Behavioural | Intubated Sevoflurane-GA group, Non-intubated TIVA-propofol group |
Primary outcome
Change in Cognitive function and delirium evaluation
Time frame: Baseline
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.
Change in Cognitive function and delirium evaluation
Time frame: Day 1 after procedure
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.
Change in Cognitive function and delirium evaluation
Time frame: Day 7 after procedure
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.
Change in Cognitive function and delirium evaluation
Time frame: Month 3 after procedure
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.
8 secondary outcomes
Neurological function: National Institute of Health Stroke Scale
Time frame: Baseline
Neurological function: National Institute of Health Stroke Scale
Time frame: Day 1 after procedure
Neurological function: National Institute of Health Stroke Scale
Time frame: Day 7 after procedure
Neurological function: National Institute of Health Stroke Scale
Time frame: Month 3 after procedure
Neurological function: modified Rankin scale
Time frame: Baseline
Neurological function: modified Rankin scale
Time frame: Day 1 after procedure
Neurological function: modified Rankin scale
Time frame: Day 7 after procedure
Neurological function: modified Rankin scale
Time frame: Month 3 after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsu Ma, MD, PhD study chair
Institutional Review Board, Taipei Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive function and delirium evaluation and Neurological functional assessment in people with Ischemic Stroke, Acute and Thrombectomy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Sung Sung, MD, PhD (886-2-28757549 ext. 320, cssung@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive function and delirium evaluation (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.