Stroke, Ischemic, Stroke/Brain Attack, Anesthesia, Hemodynamic Instability
Conditions
Brief summary
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.
Interventions
PROCEDURETCI
General anesthesia will be induced with a TCI pump
PROCEDUREManual induction
General anestehsia will be induced and maintained using a pro kilo regimen.
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Intraprocedural Hypotension | Up to three hours | Descrease of mean blood pressure \> 20% during the procedure from the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in National Institutes of Health Stroke Scale at 7 days after acute ischemic stroke | 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 |
| Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke | 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. |
| Percentage of patients alive at 3 months after acute ischemic stroke | 3 months after acute ischemic stroke | Percentage of patients alive at 3 months after acute 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 | 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 |
| Difference in time from door to groin | Up to 6 hours | Time will be evaluated from patient admission to the beginning of angiographic procedure |
| Difference in time from groin to reperfusion | Up to 6 hours | It will be evaluated the overall time of angiographic procedure |
| Difference in Intensive Care Unit/Stroke Unit stay | Up to 30 days | Overall patient stay in intensive care unit/stroke unit in days |
| Difference in modified treatment in cerebral infarction (mTICI) score | 24 hours after ischemic stroke | 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 |
Countries
Italy
Outcome results
None listed