Manually Controlled Infusion vs Target Controlled Infusion for StrokeThrombectomy

Study Overview
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Brief Summary
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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.

Official Title
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Manually Controlled Infusion vs Target Controlled Infusion: an Hemodynamic Alterations in StrokeThrombectomy Evaluation (HASTE); a Multi-center Randomized Controlled Trial

Conditions
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Stroke, Ischemic, Stroke/Brain Attack, Anesthesia, Hemodynamic Instability

Intervention / Treatment
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* Procedure: TCI
* Procedure: Manual induction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Anterior Cerebral Circulation Stroke Patient eligible for mechanical trombectomy mRS ≤ 2; Fasting patients (>6 h solid, >2 hours liquids) Glashow Coma Scale more than seven. Exclusion criteria Patient in general anesthesia at hospital arrival Associated hemorrhagic stroke

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual induction<br>General Anesthesia induction: Fentanyl 2 mcg/kg, Propofol 2 mg/kg, Rocuronium 0.6 mg/kg General Anesthesia mainteneance: Propofol 4-6 mg/kg/h to keep an adequate sedation level (BIS between 40-60; entropy between 40-60) | Procedure: Manual induction<br>* General anestehsia will be induced and maintained using a pro kilo regimen.<br>|
| Experimental: Target Controlled Induction<br>General Anesthesia induction: Fentanyl 2 mcg/kg, Propofol TCI with Schneider site effect model starting from 2 mcg/ml and increasing the dose untile loss of consciousness, Rocuronium 0.6 mg/kg. General Anesthesia mainteneance: Propofol TCI with Schneider site effect model in order to keep an adequate sedation level (BIS between 40-60; entropy between 40-60) | Procedure: TCI<br>* General anesthesia will be induced with a TCI pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Intraprocedural Hypotension | Descrease of mean blood pressure > 20% during the procedure from the baseline | Up to three hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in National Institutes of Health Stroke Scale at 24 hours after acute ischemic stroke | Change from baseline in National Institutes of Health Stroke Scale (NIHSS) at 24 hours after acute ischemic stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 | 24 hours after acute ischemic stroke | 
| Change from baseline in National Institutes of Health Stroke Scale at 7 days after acute ischemic stroke | Change from baseline in National Institutes of Health Stroke Scale (NIHSS) at 7 days after acute ischemic stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 | 7 days after acute ischemic stroke | 
| Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke | Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke. Modified Rankin Score is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is added for patients who expire. | 3 months after acute ischemic stroke | 
| Percentage of patients alive at 3 months after acute ischemic stroke | 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 | Successfull reperfusion in the two groups will be evaluated by modified tratment in cerebral infarction score. modified treatment in cerebral infarction is a five point score (0,1,2a,2b,3) with 0 menaning o reperfusion and 3 complete reperfusion | 24 hours after ischemic stroke | 
| Difference in time from door to groin | Time will be evaluated from patient admission to the beginning of angiographic procedure | Up to 6 hours | 
| Difference in time from groin to reperfusion | It will be evaluated the overall time of angiographic procedure | Up to 6 hours | 
| Difference in Intensive Care Unit/Stroke Unit stay | Overall patient stay in intensive care unit/stroke unit in days | Up to 30 days |