NCT05570682

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 9, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2022

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

September 30, 2022

Last Update Submit

March 24, 2025

Conditions

Stroke, IschemicStroke/Brain AttackAnesthesiaHemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Intraprocedural Hypotension

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

    Up to three hours

Secondary Outcomes (8)

  • 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 at 7 days after acute ischemic stroke

    7 days after acute ischemic stroke

  • Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke

    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

    24 hours after ischemic stroke

  • +3 more secondary outcomes

Study Arms (2)

Manual induction

ACTIVE COMPARATOR

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

Target Controlled Induction

EXPERIMENTAL

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

Interventions

TCIPROCEDURE

General anesthesia will be induced with a TCI pump

Target Controlled Induction
Manual inductionPROCEDURE

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

Manual induction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient in general anesthesia at hospital arrival
  • Associated hemorrhagic stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Padova

Padua, Veneto, 35127, Italy

Location

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants undergoing intervention will be unaware of the intervetion Outcomes assessor will be not involted in the other study of the study and will be not aware of the intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 6, 2022

Study Start

October 9, 2022

Primary Completion

October 9, 2022

Study Completion

October 9, 2022

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

IT(1)