- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422649
Anesthesia Technique and Outcomes in Mechanical Thrombectomy for Acute Ischemic Stroke
Comparison of General Anesthesia and Sedoanalgesia on Mortality and Neurological Outcomes in Patients Undergoing Mechanical Thrombectomy for Acute Ischemic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This retrospective observational cohort study was conducted at the University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital. Medical records of patients who underwent mechanical thrombectomy for acute ischemic stroke between 2014 and 2018 were reviewed. Patients who received mechanical thrombectomy within 6 hours of symptom onset and achieved a Thrombolysis in Cerebral Infarction (TICI) reperfusion grade of 2a, 2b, or 3 were included. Patients with TICI grades of 0 or 1, those younger than 18 years, patients with an APACHE II score ≥25, a Glasgow Coma Scale score <10, those requiring endotracheal intubation before the procedure, or patients discharged from the procedure intubated to the intensive care unit were excluded.
Based on anesthesia records, patients were classified into two cohorts: those who underwent the procedure under general anesthesia and those managed with sedoanalgesia. No assignment to anesthesia technique was performed as part of the study, and anesthesia management was determined according to routine clinical practice. Demographic characteristics, medical history, radiological findings, procedural details, and perioperative variables were extracted from hospital records. Neurological status was assessed using the National Institutes of Health Stroke Scale (NIHSS) at 4 and 24 hours after the procedure, and functional outcome was evaluated using the modified Rankin Scale during hospitalization and at 3 months after thrombectomy. Intraoperative bispectral index (BIS) values and cerebral oxygenation measured by near-infrared spectroscopy (NIRS) were recorded when available. Safety outcomes including peri-procedural hemodynamic instability, vasopressor or antihypertensive use, need for pacing, and intensive care unit (ICU) length of stay will be evaluated.
Neurological outcomes will be assessed longitudinally using NIHSS at baseline, 4 hours, 24 hours, and modified Rankin Scale (mRS/TICI) immediately after the procedure and at 3 months.
The primary outcome of the study was all-cause mortality. Secondary outcomes included neurological and functional outcomes, perioperative variables, intensive care unit length of stay, and procedure-related complications. Comparisons between anesthesia cohorts were performed using routinely collected clinical data. Postoperative delirium occurring during the first 7 days after the procedure was evaluated as a secondary safety outcome when documented in the medical records
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Outside of the US
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Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
- Fatma Acil
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Acute ischemic stroke due to large vessel occlusion (MCA M1)
- Mechanical thrombectomy performed within 6 hours of symptom onset
- Pre-procedural TICI score 0-1
Exclusion Criteria:
- Age ≥100 years
- APACHE II score of 25 or higher
- Glasgow Coma Scale score below 10
- Requirement for endotracheal intubation before the procedure
- Patients discharged from the procedure to the intensive care unit while intubated
- Time from symptom onset to procedure exceeding 6 hours
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General Anesthesia Group
Patients who underwent mechanical thrombectomy under general anesthesia, based on anesthesia records.
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Patients who underwent mechanical thrombectomy under general anesthesia, based on anesthesia records.
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|
Sedoanalgesia Group
Patients who underwent mechanical thrombectomy under sedoanalgesia, based on anesthesia records.
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Patients who underwent mechanical thrombectomy under sedoanalgesia, based on anesthesia records.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-Cause Mortality
Time Frame: During index hospitalization and at 3 months post-procedure
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Comparison of all-cause mortality between patients undergoing mechanical thrombectomy under general anesthesia and sedoanalgesia.
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During index hospitalization and at 3 months post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NIHSS Score
Time Frame: Baseline, 4 hours, 24 hours post-procedure
|
The National Institutes of Health Stroke Scale (NIHSS) is used to quantify stroke severity (score range 0-42; higher scores indicate more severe stroke)
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Baseline, 4 hours, 24 hours post-procedure
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|
Modified Rankin Scale (mRS)
Time Frame: Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy
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The modified Rankin Scale (mRS) is a global functional outcome measure used after stroke to categorize the level of functional independence.
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Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy
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|
TICI Reperfusion Grade
Time Frame: Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy.
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The Thrombolysis in Cerebral Infarction (TICI) grading system is used after endovascular revascularization to describe angiographic reperfusion (e.g., 0-3; higher grades indicate better reperfusion)
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Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy.
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Near-Infrared Spectroscopy (NIRS) Values
Time Frame: During index hospitalization and at 3 months post-procedure
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Regional cerebral oxygen saturation was monitored using near-infrared spectroscopy (NIRS) during the procedure and throughout the early postoperative period.
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During index hospitalization and at 3 months post-procedure
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Bispectral Index (BIS) Values
Time Frame: During the procedure
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Depth of anesthesia was monitored using bispectral index (BIS) values recorded during the procedure.
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During the procedure
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Procedure Duration
Time Frame: During the procedure
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Total duration of the mechanical thrombectomy procedure.
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During the procedure
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Time From Symptom Onset to Procedure
Time Frame: At the time of the procedure
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Elapsed time between symptom onset and initiation of mechanical thrombectomy.
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At the time of the procedure
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Hemodynamic Parameters
Time Frame: From procedure until 3 months post-procedure
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Systolic and diastolic blood pressure values recorded during the perioperative period
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From procedure until 3 months post-procedure
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Procedure-Related Complications
Time Frame: During hospitalization
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Occurrence of neurological or procedure-related complications during hospitalization
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During hospitalization
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Postoperative delirium
Time Frame: Within 30 days after procedure
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Incidence of postoperative delirium during the first 3 postoperative months
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Within 30 days after procedure
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Postoperative demans
Time Frame: Within 30 days after procedure
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Incidence of postoperative delirium during the first 3 postoperative months
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Within 30 days after procedure
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ICU Length of Stay
Time Frame: Through study completion, an average of 3 months
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Duration of stay in the intensive care unit following the procedure
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Through study completion, an average of 3 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01/20/2026- 13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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