Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04208477
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2019-11-21
Brief Title:
The Effect of Stellate Ganglion Block in Severe Brain Injury
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
The Effect of Stellate Ganglion Block on Brain Haemodynamics and the Inflammatory Response in Moderate and Severe Brain Injury
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Blood flow through the brain is reduced after brain damage Secondary brain ischemia caused by hypoxia and hypotension further increase the susceptibility of the ischemically compromised brain to secondary impairment during this period In order to determine whether and to what extent blockage of the stellate ganglion BSG affects the blood flow to the injured brain the investigators will measure the variables of brain blood flow before and after BSG using computed tomography angiography CTA trans-cranial Doppler ultrasound TCD intracranial pressure ICP and perfusion computed tomography PCT of the brain At the same time the investigators would like to evaluate whether and to what extent BSG affects the aseptic inflammatory brain injury response and the biochemical indicators of brain damage in patients with moderate and severe brain injury
Detailed Description:
Hypothesis
Stellate ganglion blockade in patients with moderate and severe brain damage
1 Increases the diameter of the brain arteries and blood flow through the brain
2 Do not interfere with intracranial pressure
3 Reduces aseptic inflammatory reaction of the damaged brains measured by IL-6 and reduces damage of the brain tissue measured by protein S100B S100B neuron specific enolase NSE and glial fibrillary acidic protein GFAP
Study design and method description
The study will include 40 subjects of both sexes 18-70 years old with moderate and severe head injury who will be treated surgically andor conservatively at the Intensive Care Center CIT of the Department of Anesthesiology and Intensive Care UKC Ljubljana The study will include patients who underwent computed tomography angiography of the brain CTA and received an intra-parenchymal intracranial pressure monitor electrode ICP at admission to the UKC Ljubljana Emergency Center or during CIT treatment After primary conservative or surgical care the subjects will be transferred for further treatment at CIT Subjects will be sedated and mechanically ventilated To maintain target cerabral perfusion pressure CPP the investigators will give an infusion of noradrenaline as needed The study will not include subjects with primary decompression craniectomy and radiological signs of progression of intracranial hematomas subjects in a barbiturate coma and subjects with a norepinephrine dose greater than 02 mcgkgmin The study will not include pregnant women children patients with known hypersensitivity to iodine contrast media and local anesthetics and patients with poor renal function estimated glomerular filtration below 30ml min 173m2
The research will be conducted during patient treatment at CIT The investigators will begin the investigation after positive positive opinions from the Medical Ethics Commission of the Republic of Slovenia and obtained written consent form patients family members or official legal representatives
The effect of BSG on brain blood flow and the diameter of brain vessels will be evaluated by CTA PCT TCD
BSG will be done during the first week after admission at CIT on the same patients side of the ICP position One hour after BSG control CTA in PCT will be done TCD od the left and right middle brain artery ACM will be performed one hour before and after BSG
TCD will be used to measure the rate of blood flow through ACM in systole-Vs in diastole-Vd and pulsatility index PI The investigators will compare Vs Vd values and PI before and after BSG
Possible changes in the diameter of large brain vessels after BSG will be compared between CTA done at the emergency center or during CIT treatment and a control CTA after BSG For standard diameter measurement sites the investigators will take the middle third of M1 and the proximal part of the M2 segment of the ACM the middle third of the A1 and A2 segments of the anterior brain artery ACA the P1 segment and the first part of P2 segment of the posterior brain artery ACP the terminal part of the interior carotid artery ACI the middle third of the intradural part of the vertebral artery and middle third of the basilar artery Changes in the diameter of the brain vessels will be presented numerically and descriptively
With PCT-produced color maps beside qualitative evaluation od the possible changes of the brain blood flow on the left and right brain hemisphere after BSG the investigators will also evaluate changes in regional brain blood volume rCBV regional brain blood flow rCBF mean transition time MTT Outside the contusion regions the investigators will mark the region of interest ROI of 500 mm2 for ACA ACM and ACP perfusion areas Siemens SyngoVia software will be used
PCT and CTA will be done by the helical CT tomogram Somatom Siemens Erlangen Germany A 40 ml non-ionic low-osmolar iodine contrast medium 370 mgml iopromide Ultravist Bayer HealthCare Berlin Germany will be used It will be injected at a flow rate of 5 mls into a cubital vein Perfusion imaging will be initiated 7 seconds after the injection of contrast
Blood samples for the determination of IL6 NSE S100B in GFAP will be drawn from the right external jugular vein and peripheral artery radial or femoral artery one hour before and 1 6 12 24 hours after BSG The investigators will compare IL6 NSE S100B GFAP values in venous blood from right jugular vein before v after BSG A comparation of the values of IL6 NSE S100B GFAP in venous blood from the right internal jugular vein in arterial blood taken from the peripheral artery will be done as well Blood samples will be sent for analysis to the central laboratory of UKC Ljubljana
Brain oxygenation will be measured with a non-invasive method on both fronts using Near Infrared Spectroscopy NIRS NIRS measurement values will be measured immediately before BSG and within 5 10 15 20 25 and 30 minutes after BSG
BSG will be done ipsilaterally to the inserted ICP electrode BSG will be done under ultrasound control at the C6-C7 level with a lateral approach with a Stimulplex Ultra 360 5cm needle BBrown A 6-15 MHz high frequency probe will be used BSG will be done always by the same anesthesiologist The injection site and the ultrasound probe will be aseptically prepared The ultrasound probe will be placed transversely to the neck axis at the height of the sixth cervical vertebra After preliminary verification of the needle tip position over the long cervical muscle and under the prevertebral fascia and after negative aspiration 8 ml of 05 levobupivacaine will be injected Because het investigators subjects will be sedated onset of the BSG will be confirmed 10 minutes after the blockade by the onset of three signs of Horners syndrome ptosis myosis enophthalmus anhydrosis conjunctival hyperemia enophthalmus anhydrosis conjunctival hyperemia
ICP in CPP will be continuously measured before and after BSG The data will be analyzed in graphical display using IBM SPSS Statistics statistical programs ver 25 and Microsoft Excel The variables will be presented as mean values with standard deviation or as median with interquartile range Using the paired t-test the investigators will compare the average values of the samples numerically variables Significant differences will be defined as p005
Expected results
When investigating the effect of BSG on the brain circulation and inflammatory response in subjects with moderate and severe brain damage the investigators expect a significant increase in the diameter of the large brain arteries and thus a positive effect of BSG on the brain circulation of the injured brain decreased mean blood transition time increased blood volume in the brain and increased blood flow through the brain The investigators estimate that BSG will not change the intracranial pressure The investigators expect NIRS values to be significantly higher after the blockade than before the blockade Due to the positive effects of BSG on the aseptic inflammatory response of non-injured brain BSG is expected to have the same effect in the injured brain The investigators also expect BSG will decrease the concentration of biochemical indicators of inflammation and damage to neurons and glia
Stellate ganglion blockade in patients with moderate and severe brain damage
1 Increases the diameter of the brain arteries and blood flow through the brain
2 Do not interfere with intracranial pressure
3 Reduces aseptic inflammatory reaction of the damaged brains measured by IL-6 and reduces damage of the brain tissue measured by protein S100B S100B neuron specific enolase NSE and glial fibrillary acidic protein GFAP
Study design and method description
The study will include 40 subjects of both sexes 18-70 years old with moderate and severe head injury who will be treated surgically andor conservatively at the Intensive Care Center CIT of the Department of Anesthesiology and Intensive Care UKC Ljubljana The study will include patients who underwent computed tomography angiography of the brain CTA and received an intra-parenchymal intracranial pressure monitor electrode ICP at admission to the UKC Ljubljana Emergency Center or during CIT treatment After primary conservative or surgical care the subjects will be transferred for further treatment at CIT Subjects will be sedated and mechanically ventilated To maintain target cerabral perfusion pressure CPP the investigators will give an infusion of noradrenaline as needed The study will not include subjects with primary decompression craniectomy and radiological signs of progression of intracranial hematomas subjects in a barbiturate coma and subjects with a norepinephrine dose greater than 02 mcgkgmin The study will not include pregnant women children patients with known hypersensitivity to iodine contrast media and local anesthetics and patients with poor renal function estimated glomerular filtration below 30ml min 173m2
The research will be conducted during patient treatment at CIT The investigators will begin the investigation after positive positive opinions from the Medical Ethics Commission of the Republic of Slovenia and obtained written consent form patients family members or official legal representatives
The effect of BSG on brain blood flow and the diameter of brain vessels will be evaluated by CTA PCT TCD
BSG will be done during the first week after admission at CIT on the same patients side of the ICP position One hour after BSG control CTA in PCT will be done TCD od the left and right middle brain artery ACM will be performed one hour before and after BSG
TCD will be used to measure the rate of blood flow through ACM in systole-Vs in diastole-Vd and pulsatility index PI The investigators will compare Vs Vd values and PI before and after BSG
Possible changes in the diameter of large brain vessels after BSG will be compared between CTA done at the emergency center or during CIT treatment and a control CTA after BSG For standard diameter measurement sites the investigators will take the middle third of M1 and the proximal part of the M2 segment of the ACM the middle third of the A1 and A2 segments of the anterior brain artery ACA the P1 segment and the first part of P2 segment of the posterior brain artery ACP the terminal part of the interior carotid artery ACI the middle third of the intradural part of the vertebral artery and middle third of the basilar artery Changes in the diameter of the brain vessels will be presented numerically and descriptively
With PCT-produced color maps beside qualitative evaluation od the possible changes of the brain blood flow on the left and right brain hemisphere after BSG the investigators will also evaluate changes in regional brain blood volume rCBV regional brain blood flow rCBF mean transition time MTT Outside the contusion regions the investigators will mark the region of interest ROI of 500 mm2 for ACA ACM and ACP perfusion areas Siemens SyngoVia software will be used
PCT and CTA will be done by the helical CT tomogram Somatom Siemens Erlangen Germany A 40 ml non-ionic low-osmolar iodine contrast medium 370 mgml iopromide Ultravist Bayer HealthCare Berlin Germany will be used It will be injected at a flow rate of 5 mls into a cubital vein Perfusion imaging will be initiated 7 seconds after the injection of contrast
Blood samples for the determination of IL6 NSE S100B in GFAP will be drawn from the right external jugular vein and peripheral artery radial or femoral artery one hour before and 1 6 12 24 hours after BSG The investigators will compare IL6 NSE S100B GFAP values in venous blood from right jugular vein before v after BSG A comparation of the values of IL6 NSE S100B GFAP in venous blood from the right internal jugular vein in arterial blood taken from the peripheral artery will be done as well Blood samples will be sent for analysis to the central laboratory of UKC Ljubljana
Brain oxygenation will be measured with a non-invasive method on both fronts using Near Infrared Spectroscopy NIRS NIRS measurement values will be measured immediately before BSG and within 5 10 15 20 25 and 30 minutes after BSG
BSG will be done ipsilaterally to the inserted ICP electrode BSG will be done under ultrasound control at the C6-C7 level with a lateral approach with a Stimulplex Ultra 360 5cm needle BBrown A 6-15 MHz high frequency probe will be used BSG will be done always by the same anesthesiologist The injection site and the ultrasound probe will be aseptically prepared The ultrasound probe will be placed transversely to the neck axis at the height of the sixth cervical vertebra After preliminary verification of the needle tip position over the long cervical muscle and under the prevertebral fascia and after negative aspiration 8 ml of 05 levobupivacaine will be injected Because het investigators subjects will be sedated onset of the BSG will be confirmed 10 minutes after the blockade by the onset of three signs of Horners syndrome ptosis myosis enophthalmus anhydrosis conjunctival hyperemia enophthalmus anhydrosis conjunctival hyperemia
ICP in CPP will be continuously measured before and after BSG The data will be analyzed in graphical display using IBM SPSS Statistics statistical programs ver 25 and Microsoft Excel The variables will be presented as mean values with standard deviation or as median with interquartile range Using the paired t-test the investigators will compare the average values of the samples numerically variables Significant differences will be defined as p005
Expected results
When investigating the effect of BSG on the brain circulation and inflammatory response in subjects with moderate and severe brain damage the investigators expect a significant increase in the diameter of the large brain arteries and thus a positive effect of BSG on the brain circulation of the injured brain decreased mean blood transition time increased blood volume in the brain and increased blood flow through the brain The investigators estimate that BSG will not change the intracranial pressure The investigators expect NIRS values to be significantly higher after the blockade than before the blockade Due to the positive effects of BSG on the aseptic inflammatory response of non-injured brain BSG is expected to have the same effect in the injured brain The investigators also expect BSG will decrease the concentration of biochemical indicators of inflammation and damage to neurons and glia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None