Comparison of General Anesthesia and Sedoanalgesia on Mortality and Neurological Outcomes in Patients Undergoing Mechanical Thrombectomy for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 481
- 试验地点
- 1
- 主要终点
- All-Cause Mortality
研究概览
简要总结
This retrospective cohort study examined clinical outcomes in patients who underwent mechanical thrombectomy for acute ischemic stroke under general anesthesia or sedoanalgesia. Patient data from 2014 to 2018 were obtained from hospital medical records. Mortality and neurological outcomes were compared between anesthesia groups.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
General Anesthesia Group
Patients who underwent mechanical thrombectomy under general anesthesia, based on anesthesia records.
干预措施: General Anesthesia (Other)
Sedoanalgesia Group
Patients who underwent mechanical thrombectomy under sedoanalgesia, based on anesthesia records.
干预措施: Sedoanalgesia (Other)
结局指标
主要结局
All-Cause Mortality
时间窗: During index hospitalization and at 3 months post-procedure
Comparison of all-cause mortality between patients undergoing mechanical thrombectomy under general anesthesia and sedoanalgesia.
次要结局
- NIHSS Score(Baseline, 4 hours, 24 hours post-procedure)
- Modified Rankin Scale (mRS)(Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy)
- TICI Reperfusion Grade(Immediately after completion of the angiographic procedure and at 3 months after the initial thrombectomy.)
- Near-Infrared Spectroscopy (NIRS) Values(During index hospitalization and at 3 months post-procedure)
- Bispectral Index (BIS) Values(During the procedure)
- Procedure Duration(During the procedure)
- Time From Symptom Onset to Procedure(At the time of the procedure)
- ICU Length of Stay(Through study completion, an average of 3 months)
- Hemodynamic Parameters(From procedure until 3 months post-procedure)
- Procedure-Related Complications(During hospitalization)
- Postoperative delirium(Within 30 days after procedure)
- Postoperative demans(Within 30 days after procedure)
研究者
Fatma Acil,MD
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital