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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05570682
Other study ID # HASTE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 9, 2022
Est. completion date December 2024

Study information

Verified date October 2022
Source University of Padova
Contact Alessandro De Cassai, MD
Phone +048213698
Email alessandro.decassai@aopd.veneto.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 224
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
TCI
General anesthesia will be induced with a TCI pump
Manual induction
General anestehsia will be induced and maintained using a pro kilo regimen.

Locations

Country Name City State
Italy University Hospital of Padova Padova Veneto

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with Intraprocedural Hypotension Descrease of mean blood pressure > 20% during the procedure from the baseline Up to three hours
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Difference in time from door to groin Time will be evaluated from patient admission to the beginning of angiographic procedure Up to 6 hours
Secondary Difference in time from groin to reperfusion It will be evaluated the overall time of angiographic procedure Up to 6 hours
Secondary Difference in Intensive Care Unit/Stroke Unit stay Overall patient stay in intensive care unit/stroke unit in days Up to 30 days
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