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

NCT04208477 | Completed

• 1 other identifier: UMCLjubljana Stellate
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Brain Inflammation; Cerebral Vasospasm

Keywords

stellate ganglion block; brain hemodynamics; brain inflammatory response

Outcome Measures

Primary Outcomes (1)

• Change in diameter of the cerebral arteries

  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.

  First measurement of the diameter will be done on the CTA made during the first week of hospitalization. Control measurement will be done 1 hour after the BSG.

Secondary Outcomes (12)

• Change of mean transition time (MTT) on perfusion computed tomography.

  Indicators will be measured 1 hour after the BSG

• Change of regional cerebral blood flow (rCBF) on perfusion computed tomography.

  Measurement will be measured 1 hour after the BSG

• Change of regional cerebral blood volume (rCBV) on perfusion computed tomography.

  Measurement will be measured 1 hour after the BSG

• Change of systolic velocity (sV) on transcranial Doppler ultrasound

  Measurement will be made one hour before and one hour after the BSG.

• Change of diastolic velocity (dV) on transcranial Doppler ultrasound

  Measurement will be made one hour before and one hour after the BSG.

Study Arms (1)

BSG patients

EXPERIMENTAL

Procedure: one site blockade of the stellate ganglion

Interventions

one site blockade of the stellate ganglion PROCEDURE

Ultrasound guided one site blockade of the stellate ganglion.

BSG patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with moderate and severe head injury
• patients who underwent computed tomograply angiography of the brain (CTA) at admission to the UKC Ljubljana Emergency Center or during CIT treatment
• patients with intra-parenchymal intracranial pressure monitor electrode (ICP) installed

You may not qualify if:

• patients with primary decompression craniectomy
• radiological signs of progression of intracranial hematomas
• barbiturate coma
• patients with a norepinephrine dose greater than 0.2 mcg/kg/min
• pregnant women
• children
• known hypersensitivity to iodine contrast media and local anesthetics
• poor renal function (estimated glomerular filtration below 30ml / min / 1.73m2).

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Ivan Kostadinov

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Kostadinov I, Avsenik J, Osredkar J, Jerin A, Gradisek P. Effect of stellate ganglion block on brain hemodynamics and the inflammatory response in moderate and severe traumatic brain injury: a pilot study. Reg Anesth Pain Med. 2025 Feb 19:rapm-2024-106185. doi: 10.1136/rapm-2024-106185. Online ahead of print.

  PMID: 39971387 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Encephalitis; Vasospasm, Intracranial

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neuroinflammatory Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asist Ivan Kostadinov, dr.med.EDRA

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 23, 2019
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 2 years

Locations

SL (1)