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Aneurysm, CerebralNCT03823482

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

A study testing Lidocaine in people with Aneurysm, Cerebral, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Aneurysm, Cerebral
What is being tested?
Lidocaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCroatia
Study dates
1 Mar 2019to 1 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • UHCZagreb

    Zagreb, 10000

Other trials in Croatia

About this study

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

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.

Being tested
Lidocaine
Keywords
aneurysm, cerebral, inflammation mediators, lidocaine, hydrochloride
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Also called Regional anesthesia

    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.

Study groups in NCT03823482
Study groupRoleWhat they receive
Lidocaine groupExperimentalParticipants 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.
Receives: Drug: Lidocaine
Control groupNo interventionParticipants in control group will have general anesthesia without lidocaine administration.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in concentrations of interleukin-1β

    Concentrations of IL-1β in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay

    Measured: Up to 24 hours after anesthesia induction.

  2. Change in concentrations of interleukin-6

    Concentrations of IL-6 in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay

    Measured: Up to 24 hours after anesthesia induction.

  3. Change in concentrations of tumor necrosis factor α

    Concentrations of TNF-α in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay

    Measured: Up to 24 hours after anesthesia induction.

Secondary outcomes (4)

  1. Incidence of new motoric deficit

    Clinical assessment of neurologic status incidence of generalized epileptic seizure, incidence of vasospasm, pathological finding on brain computerized tomography ( ischemia, edema, bleeding, hydrocephalus).

    Measured: Up to one week postoperatively

  2. Incidence of generalized epileptic seizure

    Clinical assessment to diagnose generalized epileptic seizure

    Measured: Up to one week postoperatively

  3. Incidence of vasospasm

    Flow velocity over middle cerebral artery more than 180 cm/s measured by transcranial ultrasound

    Measured: Up to one week postoperatively

  4. Incidence of pathological computerized tomography brain scan

    Findings of edema, ischemia, bleeding or hydrocephalus on brain CT scan

    Measured: Up to one week postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start1 Mar 2019
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion1 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03823482
Sponsor's protocol ID
51
Status last verified
Nov 2020
First submitted
24 Jan 2019
Last updated
12 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chaki T, Sugino S, Janicki PK, Ishioka Y, Hatakeyama Y, Hayase T, Kaneuchi-Yamashita M, Kohri N, Yamakage M. Efficacy and Safety of a Lidocaine and Ropivacaine Mixture for Scalp Nerve Block and Local Infiltration Anesthesia in Patients Undergoing Awake Craniotomy. J Neurosurg Anesthesiol. 2016 Jan;28(1):1-5. doi: 10.1097/ANA.0000000000000149.

    PubMed 25493926

  • Guilfoyle MR, Helmy A, Duane D, Hutchinson PJA. Regional scalp block for postcraniotomy analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 May;116(5):1093-1102. doi: 10.1213/ANE.0b013e3182863c22. Epub 2013 Mar 11.

    PubMed 23477962

  • Leng T, Gao X, Dilger JP, Lin J. Neuroprotective effect of lidocaine: is there clinical potential? Int J Physiol Pathophysiol Pharmacol. 2016 Apr 25;8(1):9-13. eCollection 2016.

    PubMed 27186318

  • Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.

    PubMed 10969322

  • Jeong HJ, Lin D, Li L, Zuo Z. Delayed treatment with lidocaine reduces mouse microglial cell injury and cytokine production after stimulation with lipopolysaccharide and interferon gamma. Anesth Analg. 2012 Apr;114(4):856-61. doi: 10.1213/ANE.0b013e3182460ab5. Epub 2012 Jan 16.

    PubMed 22253275

  • Pawlowska E, Szczepanska J, Wisniewski K, Tokarz P, Jaskolski DJ, Blasiak J. NF-kappaB-Mediated Inflammation in the Pathogenesis of Intracranial Aneurysm and Subarachnoid Hemorrhage. Does Autophagy Play a Role? Int J Mol Sci. 2018 Apr 19;19(4):1245. doi: 10.3390/ijms19041245.

    PubMed 29671828

  • Aoki T, Nishimura M. Targeting chronic inflammation in cerebral aneurysms: focusing on NF-kappaB as a putative target of medical therapy. Expert Opin Ther Targets. 2010 Mar;14(3):265-73. doi: 10.1517/14728221003586836.

    PubMed 20128708

  • Mutlu LK, Woiciechowsky C, Bechmann I. Inflammatory response after neurosurgery. Best Pract Res Clin Anaesthesiol. 2004 Sep;18(3):407-24. doi: 10.1016/j.bpa.2003.12.003.

    PubMed 15212336

  • Chaudhry SR, Stoffel-Wagner B, Kinfe TM, Guresir E, Vatter H, Dietrich D, Lamprecht A, Muhammad S. Elevated Systemic IL-6 Levels in Patients with Aneurysmal Subarachnoid Hemorrhage Is an Unspecific Marker for Post-SAH Complications. Int J Mol Sci. 2017 Dec 1;18(12):2580. doi: 10.3390/ijms18122580.

    PubMed 29194369

  • Osborn I, Sebeo J. "Scalp block" during craniotomy: a classic technique revisited. J Neurosurg Anesthesiol. 2010 Jul;22(3):187-94. doi: 10.1097/ANA.0b013e3181d48846.

    PubMed 20479675

  • Hopkins SJ, McMahon CJ, Singh N, Galea J, Hoadley M, Scarth S, Patel H, Vail A, Hulme S, Rothwell NJ, King AT, Tyrrell PJ. Cerebrospinal fluid and plasma cytokines after subarachnoid haemorrhage: CSF interleukin-6 may be an early marker of infection. J Neuroinflammation. 2012 Nov 23;9:255. doi: 10.1186/1742-2094-9-255.

    PubMed 23176037

  • Matas M, Sotosek V, Kozmar A, Likic R, Sekulic A. Effect of local anesthesia with lidocaine on perioperative proinflammatory cytokine levels in plasma and cerebrospinal fluid in cerebral aneurysm patients: Study protocol for a randomized clinical trial. Medicine (Baltimore). 2019 Oct;98(42):e17450. doi: 10.1097/MD.0000000000017450.

    PubMed 31626100

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine in people with Aneurysm, Cerebral, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in concentrations of interleukin-1β (time frame: Up to 24 hours after anesthesia induction.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03823482, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.

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