Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm.

NCT06354673 | Completed

• 1 other identifier: 278/1-April-2024
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

Neurostorming is a sudden and exaggerated stress response as a result of damage to the brain. With appropriate treatment and time, there is hope for individuals to overcome storming, regain consciousness, and work towards successfully recovering from brain injury. Most treatments for neurostorming involve the use of medications only such as dexmedetomidine, opioids, gabapentin and propofol to address secondary complications like high blood pressure and fever. These medications focus on slowing the body's stress response or relaxing the body. Stellate ganglion block (SGB) is a promising therapy for paroxysmal sympathetic hyperactivity (PSH), overcoming the limitations of systemic medications and may serve to recalibrate aberrant autonomic states. Ketamine is a potent dissociative agent which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Its combination with stellate ganglion block is to oppose its sympathomimetic effect. Dexmedetomidine has analgesic and sedative effect which inhibits the sympathetic nerve activity through its action on the α2 receptor in the spinal cord. Hypothesis: Null hypothesis: There is no difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.Alternative hypothesis: There is a difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Aim of the work is achievement of effective treatment for the neurostorm after traumatic brain injury in critically ill patients with better outcomes and decrease intensive care unit (ICU) stay.

Conditions

Paroxysmal Sympathetic Hyperactivity

Outcome Measures

Primary Outcomes (2)

• To compare the time of remission of neurostorm symptoms

  Elevated blood pressure,tachycardia, fever and tachypenea of traumatic brain injury (TBI) between the stellate ganglion block combined with either dexmedetomidine or subanesthetic keyamine infusion

  6 months

• To assess effect of stellate ganglion block combined with either dexmedetomidine or subanesthetic ketamine infusion on changes in glascow coma scale score.

  Daily evaluation of glascow coma scale score in which the lowest score is 3 ( indicates poor prognosis) and the highest is 15 (indicates the best prognosis)

  6 months

Secondary Outcomes (1)

• ▪ To measure the duration of intensive care unit (ICU) stay.

  6months

Study Arms (2)

SD group

EXPERIMENTAL

Stellate ganglion block and 1 ug/kg/h intravenous Dexmedetomidine infusion

Procedure: Stellate ganglion block; Drug: Dexmedetomidine

SK group

EXPERIMENTAL

Stellate ganglion block and 0.5 mg/kg/h intravenous ketamine infusion.

Procedure: Stellate ganglion block; Drug: Ketamine

Interventions

Stellate ganglion block PROCEDURE

Sympathectomy by using combination of regional nerve block and systemic drugs

SD group; SK group

Dexmedetomidine DRUG

intravenous Dexmedetomidine infusion

Also known as: Precedex

SD group

Ketamine DRUG

intravenous ketamine infusion

SK group

Eligibility Criteria

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

You may qualify if:

• Written informed consent from 1st degree relative.
• Physical ASA status I \& II.
• BMI less than or equal 35.
• Traumatic brain injury patients.
• Age: ≥18 years old.
• Sex: both sexes.
• Paroxysmal sympathetic hyperactivity will be diagnosed on the basis of diagnostic criteria proposed by Blackman et al.(2), The signs of PAID syndrome include: (1) Severe brain injury (Rancho Los Amigos level IV), (2) temperature of at least 38.5°C, (3) pulse of at least 130 beats/min, (4) respiratory rate of at least 140 breaths/min, (5) agitation, (6) diaphoresis, and (7) dystonia (i.e. rigidity or decerebrate posturing). The duration is at least 1 cycle/day for at least 3 days

You may not qualify if:

• \) Known hypersensitivity to study drugs. 2) Patients with primary brain stem injury or brain stem hemorrhage 3) Severe systemic organ diseases. 4) GCS score =3 points 5) Patients complicated with severe coagulation abnormalities, hemorrhagic shock, multiple organ failure.
• \) Patients with a history of cerebral hemorrhage or cerebral infarction within the past 3 months. 7) Patients complicated with a history of end stage malignancy.
• \) Patients complicated with a history of uncontrolled epilepsy.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Egypt

Location

Related Publications (7)

• Meyfroidt G, Baguley IJ, Menon DK. Paroxysmal sympathetic hyperactivity: the storm after acute brain injury. Lancet Neurol. 2017 Sep;16(9):721-729. doi: 10.1016/S1474-4422(17)30259-4.

  PMID: 28816118 BACKGROUND

• Blackman JA, Patrick PD, Buck ML, Rust RS Jr. Paroxysmal autonomic instability with dystonia after brain injury. Arch Neurol. 2004 Mar;61(3):321-8. doi: 10.1001/archneur.61.3.321.

  PMID: 15023807 BACKGROUND

• Doi S, Cho N, Obara T. Stellate ganglion block increases blood flow in the anastomotic artery after superficial temporal artery-middle cerebral artery bypass. Br J Anaesth. 2016 Sep;117(3):395-6. doi: 10.1093/bja/aew230. No abstract available.

  PMID: 27543535 BACKGROUND

• Jain V, Rath GP, Dash HH, Bithal PK, Chouhan RS, Suri A. Stellate ganglion block for treatment of cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage - A preliminary study. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):516-21. doi: 10.4103/0970-9185.86598.

  PMID: 22096287 BACKGROUND

• Lipov E, Sethi Z, Nandra G, Frueh C. Efficacy of combined subanesthetic ketamine infusion and cervical sympathetic blockade as a symptomatic treatment of PTSD/TBI in a special forces patient with a 1-year follow-up: A case report. Heliyon. 2023 Mar 27;9(4):e14891. doi: 10.1016/j.heliyon.2023.e14891. eCollection 2023 Apr.

  PMID: 37089345 BACKGROUND

• Peters AJ, Villasana LE, Schnell E. Ketamine Alters Hippocampal Cell Proliferation and Improves Learning in Mice after Traumatic Brain Injury. Anesthesiology. 2018 Aug;129(2):278-295. doi: 10.1097/ALN.0000000000002197.

  PMID: 29734230 BACKGROUND

• Browne CA, Wulf HA, Jacobson ML, Oyola MG, Wu TJ, Lucki I. Long-term increase in sensitivity to ketamine's behavioral effects in mice exposed to mild blast induced traumatic brain injury. Exp Neurol. 2022 Apr;350:113963. doi: 10.1016/j.expneurol.2021.113963. Epub 2021 Dec 28.

  PMID: 34968423 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Eslam S. Almaghawry Mohamed, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 9, 2024
• Study Start: April 4, 2024
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: December 31, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)