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

Manually Controlled Infusion vs Target Controlled Infusion: an Hemodynamic Alterations in StrokeThrombectomy Evaluation (HASTE); a Multi-center Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Stroke, Ischemic; Hemodynamic Instability; Stroke/Brain Attack
• Intervention / Treatment: Procedure: Manual induction; Procedure: TCI

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro De Cassai, MD; Phone Number: +048213698; Email: alessandro.decassai@aopd.veneto.it

Study Locations

• Italy
  • Veneto
    • Padova, Veneto, Italy, 35127
      • Recruiting
      • University Hospital of Padova
      • Contact: Alessandro De Cassai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: HASTE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No