Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lidocaine and Perioperative Cytokine Levels in Blood and Cerebrospinal Fluid in Cerebral Aneurysm Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03823482
Recruitment Status : Enrolling by invitation
First Posted : January 30, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Marijana Matas, Clinical Hospital Centre Zagreb

Brief Summary:

Cerebral aneurysm surgery has significant mortality and morbidity rate. Inflammation plays a key role in the pathogenesis of intracranial aneurysms, their rupture, subarachnoid haemorrhage and neurologic complications. Brain injury activates immune cells and triggers cytokine release. Cytokine level in blood and cerebrospinal fluid is an indicator of inflammatory response. Cytokines contribute to secondary brain injury and can worsen the outcome of the treatment. Preventing secondary brain injury by modulating inflammatory response represents a therapeutic target. Lidocaine is local anesthetic that can be used in neurosurgery for regional anesthesia of the scalp and for topical anesthesia of the throat prior to direct laryngoscopy and endotracheal intubation. Except analgetic, lidocaine has systemic anti-inflammatory and neuroprotective effect. It acts through several mechanisms on various types of immune cells producing immunosuppressing effect. Lidocaine can act on activated microglia within central nervous system causing attenuation of immune response.

Primary aim of this prospective randomized trial is to determine influence of lidocaine administration on inflammatory cytokine levels in serum and cerebrospinal fluid during and following cerebral aneurysm surgery. Secondary aim is to determine possible correlation between levels of cytokines and incidence of neurologic and infectious postoperative complications. For that purpose, postoperative neurological clinical status will be recorded. Signs of vasospasm and pathological postoperative brain CT scan findings will be recorded. Incidence of meningitis, pneumonia and sepsis in postoperative period will also be analyzed.

Hypothesis of this trial is that lidocaine administration during cerebral aneurysm surgery would significantly change levels of pro-inflammatory cytokines in cerebrospinal fluid and serum. Lower concentrations of pro-inflammatory cytokines can possibly contribute to better outcome and significantly lower incidence of postoperative complications. Enzyme-immunochemical analysis will be used to measure levels of interleukin-1β, interleukin-6 and tumor necrosis factor-α in cerebrospinal fluid and serum. Investigation group will have, during cerebrovascular surgery under general anesthesia, regional anesthesia of the scalp and topical anesthesia of the throat prior to laryngoscopy, all done with lidocaine. Control group will have general anesthesia without lidocaine administration.


Condition or disease Intervention/treatment Phase
Aneurysm, Cerebral Drug: Lidocaine Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Regional Anesthesia With Lidocaine on Perioperative Levels of Interleukin-1β, Interleukin-6 and Tumor Necrosis Factor-α in Blood and Cerebrospinal Fluid in Cerebral Aneurysm Patients
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Lidocaine group
Participants in lidocaine group, following induction to general anesthesia, will have lidocaine 2% 4 mg/kg administered as regional anesthesia of the scalp prior to Mayfield frame placement and lidocaine 1% 40 mg topically to the throat prior to direct laryngoscopy and endotracheal intubation. Maximum dosage of lidocaine won't exceed 400 mg.
Drug: Lidocaine
Administration of lidocaine 2% 4 mg/kg administered as regional anesthesia of the scalp prior to Mayfield frame placement and lidocaine 1% 40 mg topically to the throat prior to direct laryngoscopy and endotracheal intubation.
Other Name: Regional anesthesia

No Intervention: Control group
Participants in control group will have general anesthesia without lidocaine administration.



Primary Outcome Measures :
  1. Change in concentrations of interleukin-1β [ Time Frame: Up to 24 hours after anesthesia induction. ]
    Concentrations of IL-1β in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay

  2. Change in concentrations of interleukin-6 [ Time Frame: Up to 24 hours after anesthesia induction. ]
    Concentrations of IL-6 in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay

  3. Change in concentrations of tumor necrosis factor α [ Time Frame: Up to 24 hours after anesthesia induction. ]
    Concentrations of TNF-α in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay


Secondary Outcome Measures :
  1. Incidence of new motoric deficit [ Time Frame: Up to one week postoperatively ]
    Clinical assessment of neurologic status incidence of generalized epileptic seizure, incidence of vasospasm, pathological finding on brain computerized tomography ( ischemia, edema, bleeding, hydrocephalus).

  2. Incidence of generalized epileptic seizure [ Time Frame: Up to one week postoperatively ]
    Clinical assessment to diagnose generalized epileptic seizure

  3. Incidence of vasospasm [ Time Frame: Up to one week postoperatively ]
    Flow velocity over middle cerebral artery more than 180 cm/s measured by transcranial ultrasound

  4. Incidence of pathological computerized tomography brain scan [ Time Frame: Up to one week postoperatively ]
    Findings of edema, ischemia, bleeding or hydrocephalus on brain CT scan


Other Outcome Measures:
  1. Incidence of meningitis, pneumonia and sepsis [ Time Frame: Up to one week postoperatively ]
    Clinical signs and laboratory findings for diagnosing infectious complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA ( American Society of Anesthesiologists) grading status I-III,
  • scheduled for cerebral aneurysm surgery under general anesthesia,
  • signed informed consent for participating in the research.

Exclusion Criteria:

  • poorly controlled chronic or acute cardiovascular, respiratory or autoimmune disease,
  • acute infectious disease,
  • renal or hepatic insufficiency,
  • preoperative Glasgow Coma Scale score lower than 15,
  • allergic reaction to any of the medications in protocol,
  • pregnancy
  • refusal to participate in the research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823482


Locations
Layout table for location information
Croatia
UHCZagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
Clinical Hospital Centre Zagreb

Publications:

Layout table for additonal information
Responsible Party: Marijana Matas, Principal Investigator, Clinical Hospital Centre Zagreb
ClinicalTrials.gov Identifier: NCT03823482     History of Changes
Other Study ID Numbers: 51
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marijana Matas, Clinical Hospital Centre Zagreb:
aneurysm, cerebral
inflammation mediators
lidocaine, hydrochloride

Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Intracranial Aneurysm
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action