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Manually Controlled Infusion vs Target Controlled Infusion for StrokeThrombectomy (HASTE)

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ClinicalTrials.gov Identifier: NCT05570682
Recruitment Status : Recruiting
First Posted : October 6, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Alessandro De Cassai, University of Padova

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Stroke/Brain Attack Anesthesia Hemodynamic Instability Procedure: TCI Procedure: Manual induction Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Primary Purpose: Treatment
Official Title: Manually Controlled Infusion vs Target Controlled Infusion: an Hemodynamic Alterations in StrokeThrombectomy Evaluation (HASTE); a Multi-center Randomized Controlled Trial
Actual Study Start Date : October 9, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Manual induction
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 anestehsia will be induced and maintained using a pro kilo regimen.
Experimental: Target Controlled 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with Intraprocedural Hypotension [ Time Frame: Up to three hours ]
    Descrease of mean blood pressure > 20% during the procedure from the baseline


Secondary Outcome Measures :
  1. Change from baseline in National Institutes of Health Stroke Scale at 24 hours after acute ischemic stroke [ Time Frame: 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

  2. Change from baseline in National Institutes of Health Stroke Scale at 7 days after acute ischemic stroke [ Time Frame: 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

  3. Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke [ Time Frame: 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.

  4. Percentage of patients alive at 3 months after acute ischemic stroke [ Time Frame: 3 months after acute ischemic stroke ]
    Percentage of patients alive at 3 months after acute ischemic stroke

  5. Difference in modified treatment in cerebral infarction (mTICI) score [ Time Frame: 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

  6. Difference in time from door to groin [ Time Frame: Up to 6 hours ]
    Time will be evaluated from patient admission to the beginning of angiographic procedure

  7. Difference in time from groin to reperfusion [ Time Frame: Up to 6 hours ]
    It will be evaluated the overall time of angiographic procedure

  8. Difference in Intensive Care Unit/Stroke Unit stay [ Time Frame: Up to 30 days ]
    Overall patient stay in intensive care unit/stroke unit in days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05570682


Contacts
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Contact: Alessandro De Cassai, MD +048213698 alessandro.decassai@aopd.veneto.it

Locations
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Italy
University Hospital of Padova Recruiting
Padova, Veneto, Italy, 35127
Contact: Alessandro De Cassai, MD         
Sponsors and Collaborators
University of Padova
More Information
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Responsible Party: Alessandro De Cassai, Medical Doctor, University of Padova
ClinicalTrials.gov Identifier: NCT05570682    
Other Study ID Numbers: HASTE
First Posted: October 6, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases