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

Primary Purpose

Stroke, Ischemic, Stroke/Brain Attack, Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TCI
Manual induction
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of PadovaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual induction

Target Controlled Induction

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Number of patients with Intraprocedural Hypotension
Descrease of mean blood pressure > 20% during the procedure from the baseline

Secondary Outcome Measures

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
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
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.
Percentage of patients alive at 3 months after acute ischemic stroke
Percentage of patients alive at 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
Difference in time from door to groin
Time will be evaluated from patient admission to the beginning of angiographic procedure
Difference in time from groin to reperfusion
It will be evaluated the overall time of angiographic procedure
Difference in Intensive Care Unit/Stroke Unit stay
Overall patient stay in intensive care unit/stroke unit in days

Full Information

First Posted
September 30, 2022
Last Updated
October 9, 2022
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT05570682
Brief Title
Manually Controlled Infusion vs Target Controlled Infusion for StrokeThrombectomy
Acronym
HASTE
Official Title
Manually Controlled Infusion vs Target Controlled Infusion: an Hemodynamic Alterations in StrokeThrombectomy Evaluation (HASTE); a Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke/Brain Attack, Anesthesia, Hemodynamic Instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual induction
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Target Controlled Induction
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
TCI
Intervention Description
General anesthesia will be induced with a TCI pump
Intervention Type
Procedure
Intervention Name(s)
Manual induction
Intervention Description
General anestehsia will be induced and maintained using a pro kilo regimen.
Primary Outcome Measure Information:
Title
Number of patients with Intraprocedural Hypotension
Description
Descrease of mean blood pressure > 20% during the procedure from the baseline
Time Frame
Up to three hours
Secondary Outcome Measure Information:
Title
Change from baseline in National Institutes of Health Stroke Scale at 24 hours after acute ischemic stroke
Description
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
Title
Change from baseline in National Institutes of Health Stroke Scale at 7 days after acute ischemic stroke
Description
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
Title
Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke
Description
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
Title
Percentage of patients alive at 3 months after acute ischemic stroke
Description
Percentage of patients alive at 3 months after acute ischemic stroke
Time Frame
3 months after acute ischemic stroke
Title
Difference in modified treatment in cerebral infarction (mTICI) score
Description
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
Title
Difference in time from door to groin
Description
Time will be evaluated from patient admission to the beginning of angiographic procedure
Time Frame
Up to 6 hours
Title
Difference in time from groin to reperfusion
Description
It will be evaluated the overall time of angiographic procedure
Time Frame
Up to 6 hours
Title
Difference in Intensive Care Unit/Stroke Unit stay
Description
Overall patient stay in intensive care unit/stroke unit in days
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro De Cassai, MD
Phone
+048213698
Email
alessandro.decassai@aopd.veneto.it
Facility Information:
Facility Name
University Hospital of Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro De Cassai, MD

12. IPD Sharing Statement

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Manually Controlled Infusion vs Target Controlled Infusion for StrokeThrombectomy

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