Lidocaine and Perioperative Cytokine Levels in Blood and Cerebrospinal Fluid in Cerebral Aneurysm Patients
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|ClinicalTrials.gov Identifier: NCT03823482|
Recruitment Status : Enrolling by invitation
First Posted : January 30, 2019
Last Update Posted : April 18, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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
- 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
- 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
- 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).
- Incidence of generalized epileptic seizure [ Time Frame: Up to one week postoperatively ]Clinical assessment to diagnose generalized epileptic seizure
- 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
- 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
- Incidence of meningitis, pneumonia and sepsis [ Time Frame: Up to one week postoperatively ]Clinical signs and laboratory findings for diagnosing infectious complications
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
|Zagreb, Croatia, 10000|