Manually Controlled Infusion Vs Target Controlled Infusion for StrokeThrombectomy

Not Applicable

Withdrawn

• Conditions: Anesthesia; Hemodynamic Instability; Stroke/Brain Attack; Stroke, Ischemic
• Interventions: Procedure: TCI; Procedure: Manual induction

• Registration Number: NCT05570682
• Lead Sponsor: University of Padova

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-06
• Study Start: 2022-10-09
• Primary Completion: 2022-10-09
• Study Completion: 2022-10-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 224

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Target Controlled Induction	TCI	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)
Manual induction	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)

Primary Outcome Measures

Name	Time	Method
Number of patients with Intraprocedural Hypotension	Up to three hours	Descrease of mean blood pressure \> 20% during the procedure from the baseline

Secondary Outcome Measures

Name	Time	Method
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
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
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
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.
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
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 Intensive Care Unit/Stroke Unit stay	Up to 30 days	Overall patient stay in intensive care unit/stroke unit in days
Difference in time from groin to reperfusion	Up to 6 hours	It will be evaluated the overall time of angiographic procedure

Trial Locations

Locations (1)

University Hospital of Padova; 🇮🇹 Padova, Veneto, Italy