NCT05570682撤回不适用
Manually Controlled Infusion Vs Target Controlled Infusion: an Hemodynamic Alterations in StrokeThrombectomy Evaluation (HASTE); a Multi-center Randomized Controlled Trial
University of Padova2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2022年10月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Number of patients with Intraprocedural Hypotension
研究概览
简要总结
The goal of this randomized controlled trial is to compare manual general anesthesia induction to general anesthesia induction guided by target controlled infusion system in cerebral ischemic stroke
The main questions it aims to answer are:
- Does target controlled infusion has a more favorauble hemodynamic profile than manual general anesthesia induction?
- Do patients receiving general anesthesia with target controlled infusion system have a more favourable outcome? Participants will receive general anesthesia induction with a target controlled infusion system and will be compared to patients receiving manual general anesthesia induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants undergoing intervention will be unaware of the intervetion Outcomes assessor will be not involted in the other study of the study and will be not aware of the intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Anterior Cerebral Circulation Stroke
- •Patient eligible for mechanical trombectomy
- •Fasting patients (>6 h solid, >2 hours liquids)
- •Glashow Coma Scale more than seven.
排除标准
- •Patient in general anesthesia at hospital arrival
- •Associated hemorrhagic stroke
结局指标
主要结局
Number of patients with Intraprocedural Hypotension
时间窗: Up to three hours
Descrease of mean blood pressure \> 20% during the procedure from the baseline
次要结局
- Percentage of patients alive at 3 months after acute ischemic stroke(3 months after acute ischemic stroke)
- Difference in modified treatment in cerebral infarction (mTICI) score(24 hours after ischemic stroke)
- Change from baseline in National Institutes of Health Stroke Scale at 24 hours after acute ischemic stroke(24 hours after acute ischemic stroke)
- Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke(3 months after acute ischemic stroke)
- Change from baseline in National Institutes of Health Stroke Scale at 7 days after acute ischemic stroke(7 days after acute ischemic stroke)
- Difference in time from door to groin(Up to 6 hours)
- Difference in Intensive Care Unit/Stroke Unit stay(Up to 30 days)
- Difference in time from groin to reperfusion(Up to 6 hours)
研究者
Alessandro De Cassai
Medical Doctor
University of Padova
研究点 (2)
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