Manually Controlled Infusion vs Target Controlled Infusion for StrokeThrombectomy

Anesthesia Clinical Trial

— HASTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570682
• Other study ID #: HASTE
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Hemodynamic Instability
• Ischemic Stroke
• Stroke
• Stroke, Ischemic
• Stroke/Brain Attack

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