Manually Controlled Infusion Vs Target Controlled Infusion for StrokeThrombectomy

University of Padova

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Stroke, Ischemic Stroke/Brain Attack Anesthesia Hemodynamic Instability

Interventions

TCIPROCEDURE

General anesthesia will be induced with a TCI pump

Manual inductionPROCEDURE

General anestehsia will be induced and maintained using a pro kilo regimen.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Padova

Padova, Veneto, Italy

Outcomes

Primary Outcomes

Number of patients with Intraprocedural Hypotension

Descrease of mean blood pressure \> 20% during the procedure from the baseline

Time frame: Up to three hours

Secondary Outcomes

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

Data from ClinicalTrials.gov

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