Clinical trial • Not applicable • Other

LIDOCAINE HYDROCHLORIDE for Acute ischemic stroke

Not applicable trial of LIDOCAINE HYDROCHLORIDE for Acute ischemic stroke.

Overview

Trial Therapeutic Area
Other
Trial Disease
Acute ischemic stroke
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
26-06-2024
First CTIS Authorization Date
14-08-2024

Trial design

Randomised, two arms: hfnc arm — patients receive iv lidocaine bolus 1 mg/kg and continuous propofol infusion via tci starting at target plasma concentration 1.5 mcg/ml (adjusted to maintain bis 60-80); endovascular access infiltrated under local anesthesia; hfnc flow 40-60 (protocol) with minimum fio2 to maintain targets. ga arm — intravenous induction with lidocaine iv bolus 1 mg/kg, fentanyl 1.5 mcg/kg, propofol in tci starting at plasma concentration 3 mcg/ml (adjusted to maintain bis 40-60), and rocuronium 1 mg/kg; fentanyl boluses or other analgesics at anesthesiologist discretion; ventilatory parameters and fio2 adjusted to maintain goals.-controlled Not applicable trial in Spain.

Randomised
Yes
Comparator
Two arms: HFNC arm — patients receive IV lidocaine bolus 1 mg/kg and continuous propofol infusion via TCI starting at target plasma concentration 1.5 mcg/ml (adjusted to maintain BIS 60-80); endovascular access infiltrated under local anesthesia; HFNC flow 40-60 (protocol) with minimum FiO2 to maintain targets. GA arm — intravenous induction with lidocaine IV bolus 1 mg/kg, fentanyl 1.5 mcg/kg, propofol in TCI starting at plasma concentration 3 mcg/ml (adjusted to maintain BIS 40-60), and rocuronium 1 mg/kg; fentanyl boluses or other analgesics at anesthesiologist discretion; ventilatory parameters and FiO2 adjusted to maintain goals.
Target Sample Size
116
Trial Duration For Participant
90

Eligibility

Recruits 116 No vulnerable population selected. Informed consent: "Informed consent signed by the patient if capable, or by a family member/legal representative if the patient is not capable." (Consent by legal representative allowed if patient not capable.).

Vulnerable Population
No vulnerable population selected. Informed consent: "Informed consent signed by the patient if capable, or by a family member/legal representative if the patient is not capable." (Consent by legal representative allowed if patient not capable.)

Inclusion criteria

  • {"criterion_text":"- Age greater than or equal to 18 years."}
  • {"criterion_text":"- NIHSS ≥ 6 and ≤ 25."}
  • {"criterion_text":"- Anterior circulation stroke with isolated or combined occlusion of: - Intracranial Internal Carotid Artery. - Middle Cerebral Artery in its M1 or M2 segments."}
  • {"criterion_text":"- Time of evolution from clinical onset to radiology ward admission < 6 hours, or < 24 hours since last seen asymptomatic if salvageable tissue is demonstrated on neuroimaging tests."}
  • {"criterion_text":"- Informed consent signed by the patient if capable, or by a family member/legal representative if the patient is not capable."}

Exclusion criteria

  • {"criterion_text":"- Coma on admission (Glasgow Coma Scale < 8)."}
  • {"criterion_text":"- Baseline severe dependency status (mRS>3)."}
  • {"criterion_text":"- Severe/significant agitation on admission."}
  • {"criterion_text":"- Objective loss of airway protection reflexes or vomiting on admission."}
  • {"criterion_text":"- Failure to comply with fasting (6 hours of solids and 2 hours of clear liquids)."}
  • {"criterion_text":"- Known or suspected difficult airway on examination."}
  • {"criterion_text":"- Allergy or intolerance to any of the medications used for sedation or general anesthesia."}
  • {"criterion_text":"- Recent maxillofacial trauma/surgery."}
  • {"criterion_text":"- Acute cerebral hemorrhage or clear hemorrhagic transformation in the same vascular territory."}
  • {"criterion_text":"- Thrombopenia <50,000 or severe coagulation disturbances."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time between arrival at the hospital door and arterial recanalization (in minutes). This time has been shown to be sensitive to the type of anesthetic procedure used in the different meta-analyses published and, in addition to including the time of the intervention, which may also be influenced by the anesthetic technique, it is less affected by other factors than other times collected for the assessment of stroke treatment, such as the time from onset of the clinic to recanalization.","definition_or_measurement_approach":"Measured in minutes from hospital arrival (door) to arterial recanalization; timepoint recorded during procedure (arterial recanalization defined per procedural records)."}

Secondary endpoints

  • {"endpoint_text":"- NIHSS scale at 24 hours and the modified Rankin scale (mRS) 90 days after stroke.","definition_or_measurement_approach":"NIHSS assessed at 24 hours. mRS assessed at 90 days by telephone or face-to-face interview."}
  • {"endpoint_text":"- Door time - arterial puncture: minutes. Arterial puncture time - recanalization: minutes","definition_or_measurement_approach":"Measured in minutes for the specified intervals: (1) hospital door to arterial puncture; (2) arterial puncture to recanalization; times recorded from clinical/procedural timestamps."}
  • {"endpoint_text":"- Degree of arterial recanalization, according to the mTICI scale (modified Thrombolysis in Cerebral Infarction Scale): 0-3","definition_or_measurement_approach":"mTICI score (0-3) assigned after treatment to describe degree of arterial recanalization."}
  • {"endpoint_text":"- Incidence of complications during the intervention in both groups (arterial perforation, dissection, embolisms to new territories, complications at the point of arterial puncture, arterial hypertension or hypotension, arrhythmias, hypoxemia, and bronchial aspiration) as well as after the procedure (cerebral hemorrhage, hypertension or hypotension, arrhythmias, hypoxemia or pneumonia). Their presence will be assessed after 24 hours, and upon discharge from hospital.","definition_or_measurement_approach":"Complications tracked during procedure and after; presence recorded at 24 hours and at hospital discharge, with events categorised as listed (arterial perforation, dissection, etc.)."}

Recruitment

Planned Sample Size
116
Recruitment Window Months
36
Consent Approach
Informed consent to be signed by the patient if capable, or by a family member/legal representative if the patient is not capable. A subject information and informed consent form document is listed (no languages or age-specific documents specified).

Geography

Total Number Of Sites
1
Total Number Of Participants
116

Spain

Earliest CTIS Part Ii Submission Date
18-07-2024
Latest Decision Or Authorization Date
10-09-2024
Processing Time Days
54
Number Of Sites
1
Number Of Participants
116

Sites

Site Name
Hospital Universitario La Paz
Department Name
Radiología
Principal Investigator Name
Pedro Navia Álvarez
Principal Investigator Email
pnavia1@gmail.com
Contact Person Name
Pedro Navia Álvarez
Contact Person Email
pnavia1@gmail.com
Number Of Participants
116

Sponsor

Primary sponsor

Full Name
Hospital Universitario La Paz
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Lidocaína B. Braun 10 mg/ml solución inyectable
Active Substance
LIDOCAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Marketing authorisation number: 44.793
Starting Dose
IV lidocaine bolus 1 mg/kg (per protocol arms)
Dose Levels
Bolus 1 mg/kg; max reported amount 1 (mg/kg) in product record
Frequency
Single bolus (as per induction described)
Maximum Dose
1 mg/kg
Investigational Product Name
Propofol Fresenius 10 mg/ml emulsión para inyección o perfusión
Active Substance
PROPOFOL
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous (TCI infusion)
Authorisation Status
Marketing authorisation number: 62.134
Starting Dose
TCI starting target plasma concentration 1.5 mcg/ml (HFNC arm) and 3 mcg/ml (GA arm)
Dose Levels
Initial 1.5 mcg/ml (HFNC) or 3 mcg/ml (GA); may be modified to maintain BIS targets
Frequency
Continuous infusion (TCI) during procedure
Maximum Dose
3 (units as per product record)
Investigational Product Name
Fentanest 0,05 mg/ml solución inyectable
Active Substance
FENTANYL CITRATE
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Marketing authorisation number: 41.764
Starting Dose
Fentanyl 1.5 mcg/kg bolus during induction (GA arm)
Dose Levels
Bolus 1.5 mcg/kg; additional boluses as needed at anesthesiologist discretion
Frequency
Bolus with additional boluses as required
Maximum Dose
1.5 mcg/kg
Investigational Product Name
Esmeron 10 mg/ml solución inyectable y para perfusión
Active Substance
ROCURONIUM BROMIDE
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Marketing authorisation number: 61141
Starting Dose
Rocuronium 1 mg/kg (GA arm induction)
Dose Levels
1 mg/kg single dose for induction (per protocol)
Frequency
Single bolus at induction
Maximum Dose
1 mg/kg
Investigational Product Name
Aire medicinal sintético Carburos Metálicos, 22% v/v, gas medicinal, comprimido
Active Substance
OXYGEN
Modality
Small molecule
Routes Of Administration
Inhalation (gas)
Route
Inhalation gas (HFNC)
Authorisation Status
Marketing authorisation number: 71.855
Starting Dose
HFNC flow rate between 40-60 (according to patient tolerance) with minimum FiO2 necessary to maintain targets
Dose Levels
Flow 40-60 (protocol-specified), FiO2 adjusted to clinical targets
Frequency
Continuous during procedure as required
Maximum Dose
60 (product record unit: Other)
Combination Treatment
Yes

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