An interventional study of TCI and Manual induction in Stroke, Ischemic, Stroke/Brain Attack and Anesthesia, sponsored by University of Padova. Withdrawn at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of Padova · Not applicable, Interventional, and Treatment
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:
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
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Exclusion criteria
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
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
General anesthesia will be induced with a TCI pump
General anestehsia will be induced and maintained using a pro kilo regimen.
Number of patients with Intraprocedural Hypotension
Descrease of mean blood pressure \> 20% during the procedure from the baseline
Time frame: Up to three hours
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 6 hours
Difference in time from groin to reperfusion
It will be evaluated the overall time of angiographic procedure
Time frame: Up to 6 hours
Difference in Intensive Care Unit/Stroke Unit stay
Overall patient stay in intensive care unit/stroke unit in days
Time frame: Up to 30 days
This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Padova