Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Nervous System Diseases

Symptoms and General Pathology

Ganglion Cysts

Aneurysm

Intracranial Aneurysm

Synovial Cyst

Cysts

Vascular Diseases

Mucinoses

Connective Tissue Diseases

Intracranial Arterial Diseases

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Ropivacaine

Anesthetics, Local

Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 6-8mL on the right side at the level of the sixth cervical vertebrae (C6) before surgery.Then the catheter will be attached to a single use patient-controlled analgesia pump containing 0.2% ropivacaine 150 mL, which will be infused at 2 mL/h.

In the control group, every thing will be conducted as a matter of routine without intervention.

stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)

Stellate Ganglion Block

Xu Wang

To investigate whether stellate ganglion block is helpful to brain protection during cranial aneurysm surgery

The vasospasm after cranial aneurysm surgery have a higher incidence, but not have an ideal treatment method. At present, the medical treatment is very limited effect to prevent the perioperative cerebral ischemia.Stellate ganglion block （SGB）is an effective and well-tolerated approach to the treatment of CVS in various clinical settings.Resent study indicated that SGB has a protective effect on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage.Therefore,we hypothesized that the preoperative SGB would be a effective treatment for improvement of vasospasm after cranial aneurysm surgery.

Perioperative Neuroprotection of Stellate Ganglion Block

Preventive Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients Undergoing Aneurysm Surgery

The postoperative recovery quality will be evaluated by using of the Post-operative Quality Recovery Scale (PQRS)

The occurrence of cerebral vasospasm will be diagnosed by using of the transcranial doppler instrument.

Cerebral oxygen metabolism will be monitored through jugular venous oxygen saturation (SjVO2) and cerebral extraction rate of oxygen (CERO2), and measured by blood gas analysis at each time point, the latter will be calculated using the formula:

CaO2 = (Hb\*1.38\*SaO2) + (0.003\*PaO2); CvO2 = (Hb\*1.38\*SjvO2) + (0.003\*PjvO2); CERO2 = (CaO2-CvO2)/CaO2 where CaO2 is arterial oxygen content, Hb is arterial hemoglobin concentration, SaO2 is arterial oxygen saturation, PaO2 is the arterial partial pressure of oxygen, CvO2 is mixed venous oxygen content and PjvO2 is the jugular venous partial pressure of oxygen.

A 5-mL jugular venous blood sample will be taken at each time point, centrifuged at 3,000 rpm for 25 min, and kept in a freezer at -80°C until analysis. the concentrations of plasma endothelin, melatonin, and S100-β protein will be measured using enzyme-linked immunosorbent assays.

The postoperative cognitive function will be measured by using of the mini-mental state examination (MMSE).

General Hospital of Ningxia Medical University

Hemorrhage

Subarachnoid Hemorrhage

Neoplasm Metastasis

Emergencies

Vasospasm, Intracranial

Intracranial Hemorrhages

Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery.

Patients were then assessed using transcranial Doppler

patients will receive a stellate ganglion block with 0.9% saline 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery.

Patients were then assessed using transcranial Doppler

Stellate ganglion block under ultra-guide will be administered using 0.25% ropivacaine 10mL

Stellate ganglion block under ultra-guide will be administered using 0.9% saline 10mL

Placebo

To investigate whether the stellate ganglion block is helpful in relieving cerebral vasospasm during aneurysmal coil embolism surgery. The effect was assessed by Transcranial Doppler (TCD).

Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients With Emergency Aneurysmal Subarachnoid Hemorrhage

Beijing Tiantan Hospital

Vice Professor

Wounds and Injuries

Infections

Inflammation

Encephalitis

Brain Injuries

Brain Injuries, Traumatic

Infectious Encephalitis

Craniocerebral Trauma

Trauma, Nervous System

Neuroinflammatory Diseases

Ultrasound guided one site blockade of the stellate ganglion.

one site blockade of the stellate ganglion

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.

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 and/or 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 0.2 mcg/kg/min. 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 / 1.73m2).

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 patient's 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 patient's 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 mg/ml iopromide (Ultravist; Bayer HealthCare, Berlin, Germany) will be used. It will be injected at a flow rate of 5 ml/s 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 (B.Brown). 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 0.5% levobupivacaine will be injected. Because het investigator's subjects will be sedated, onset of the BSG will be confirmed 10 minutes after the blockade, by the onset of three signs of Horner's 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 sample's numerically variables. Significant differences will be defined as p\<0,05.

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.

"The Effect of Stellate Ganglion Block in Severe Brain Injury"

"The Effect of Stellate Ganglion Block on Brain Haemodynamics and the Inflammatory Response in Moderate and Severe Brain Injury"

Diameters of the cerebral arteries will be measured in millimeters (mm) on the CTA before and after BSG. Measurement of the diameter will be done on standard positions: middle third of M1 segment and upper part of M2 segment of middle cerebral artery, middle third of A1 and A2 segment of anterior cerebral artery, P1 segment and first part of P2 segment of posterior cerebral artery, terminal part of internal carotid artery, middle third of the intradural part of vertebral artery and middle third of basilar artery.

Measurement will be mede with perfusion computed tomography done after one side BSG (left or right, depending of the side of ICP electrode position). Comparation will be made between left and right hemisphere. Measures will be expressed seconds.

Measurement will be mede with perfusion computed tomography done after one side BSG (left or right, depending of the side of ICP electrode position). Comparation will be made between left and right hemisphere. Measures will be expressed ml/100g brain tissue/min.

Measurement will be mede with perfusion computed tomography done after one side BSG (left or right, depending of the side of ICP electrode position). Comparation will be made between left and right hemisphere. Measures will be expressed ml/100g brain tissue.

With transcranial Doppler measurement of systolic velocity (sV) will be made on middle cerebral artery and expressed in cm/s.

With transcranial Doppler measurement of diastolic velocity (dV) will be made on middle cerebral artery and expressed in cm/s.

With transcranial Doppler measurement of pulsatility index will be made on middle cerebral artery.

Brain tissue oxygenation will be measured with near infrared spectroscopy (NIRS) on both sides of the head.

Intracranial pressure will be measured with the intracranial pressure electrode in mmHg.

The investigators will measure plasma interleucin 6 (IL-6) in micrograms/mL. Blood samples will be taken from arterial line and right deep jugular vein.

The investigators will measure plasma protein S100B in mcg/L. Blood samples will be taken from arterial line and right deep jugular vein.

The investigators will measure plasma neuron specific enolase (NSE) in micrograms/L. Blood samples will be taken from arterial line and right deep jugular vein.

The investigators will measure plasma glial fibrillary acidic protein (GFAP) in micrograms/L. Blood samples will be taken from arterial line and right deep jugular vein.

University Medical Centre Ljubljana

asist Ivan Kostadinov, dr.med.EDRA

In addition to routine anesthesia management and surgical operations, a stellate ganglion block was performed before induction of anesthesia, and then receive standard care after operation. Related statistical indicators were collected prospectively.

In this study, a blank control was used. Routine anesthesia management and surgical operation were used without any special interventions(only an camouflaging action), and then receive standard care after operation. Only relevant statistical indicators were collected prospectively.

After the patient entered the operating room, early SGB will be performed by a designated experienced anesthesiologist using the B-ultrasound visualization technique. The intervention site is the ipsilateral side of the planned craniotomy site. After routine disinfection, 0.5% ropivacaine 8-10 mL will be injected into the surface of the longus colli muscle on the medial side of the prevertebral fascia at the level of the C6 anterior tubercle, and then the puncture point will be covered with sterile dressings. The success criteria of e-SGB are Horner's syndrome, which is characterized by a miosis, ptosis, enophthalmos, conjunctival hyperemia and facial reddishness without sweating. For the "camouflaging" arm, the anesthesiologist only covered the corresponding part of the patient with sterile dressings to confuse the follow-up, without any puncture. All patients will be admitted to the ICU after the operation and then receive the standard of care.

Stellate ganglion block

Ruquan Han, M.D., Ph.D

At present, cerebral vasospasm (cVS) is the main cause of delayed cerebral infarction (DCI), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. As a consequence, the key of reducing DCI is to prevent cVS. But unfortunately, despite years of efforts, the prevention and treatment of cVS is still a major clinical dilemma and various ways of treatment are still being explored. Recent studies have shown that stellate ganglion block (SGB) can dilate cerebral vessels and alleviate the impact of existing cVS. However, there is no study to evaluate the effect of early application of SGB on the improvement and prevention of cVS after aSAH.

Cerebral vasospasm refers to the extensive segmental or diffuse contraction of cerebral vasculature after aSAH, and cerebral blood flow is significantly reduced, which can lead to delayed cerebral ischemia (DCI) or delayed ischemic neurological dysfunction (DIND). Past studies have shown that if cerebral vasospasm occurs in patients with aSAH, the proportion of ischemic brain injury can be as high as 20%-30%.Obviously, prevention and treatment of CVS are the key to reducing the disability and mortality of aSAH.

Stellate Ganglion Block and Cerebral Vasospasm

Effect of Early Stellate Ganglion Block for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial (BLOCK-CVS)

Symptomatic vasospasm is defined as new focal or global neurological dysfunction or a decrease in the Glasgow coma score by more than 2 points, and with angiographic vasospasm on TCD or CTA.

The mean blood flow velocity (MFV) of the middle cerebral artery ≥ 120 cm/s or Lindegaard index (ratio of MFV of the middle cerebral artery to the internal carotid artery) ≥ 3.

Compared with the preoperative baseline, the corresponding vessel diameter narrowed by more than 30% or new segmental stenosis occurred, not related to atherosclerosis or mechanical artery stenosis caused by arterial clamps or coils.

The incidence of hypoperfusion in CTP diagnosis

New cerebral infarction is defined only as the appearance of new low-density infarct shadow on CT image compared with preoperation.

the changes in the mean blood flow velocity (mBFV) of all large intracranial anterior circulation vessels

The modified Rankin scale ≤2 is defined as good prognosis

Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Neuroprotection of Stellate Ganglion Block	NCT02275247	Intracranial An...	Stellate Gangli...	20 Years - 60 Years	General Hospital of Ningxia Medical University
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage	NCT04512859	Subarachnoid He... Cerebral Vasosp...	Stellate Gangli... Placebo	18 Years - 65 Years	Beijing Tiantan Hospital
"The Effect of Stellate Ganglion Block in Severe Brain Injury"	NCT04208477	Traumatic Brain... Brain Inflammat... Cerebral Vasosp...	one site blocka...	18 Years - 70 Years	University Medical Centre Ljubljana
Stellate Ganglion Block and Cerebral Vasospasm	NCT04691271	Aneurysmal Suba... Stellate Gangli... Cerebral Vasosp...	Stellate gangli...	18 Years - 65 Years	Beijing Tiantan Hospital
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage	NCT04512859	Subarachnoid He... Cerebral Vasosp...	Stellate Gangli... Placebo	18 Years - 65 Years	Beijing Tiantan Hospital

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