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No particpants was enrolled as after IRB cleareance there was no more logistical feasibiliy to enroll patients.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual induction | Active Comparator | 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) |
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| Target Controlled Induction | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCI | Procedure | General anesthesia will be induced with a TCI pump |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Padova | Padova | Veneto | 35127 | Italy |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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
| Manual induction |
| Procedure |
General anestehsia will be induced and maintained using a pro kilo regimen. |
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |