Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm.
NCT06354673 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205
Last updated 2025-12-31
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
Interventions
- DRUG
-
Dexmedetomidine
intravenous Dexmedetomidine infusion
- DRUG
-
intravenous ketamine infusion
- PROCEDURE
-
Stellate ganglion block
Sympathectomy by using combination of regional nerve block and systemic drugs
Sponsors & Collaborators
-
Zagazig University
lead OTHER_GOV
Principal Investigators
-
Eslam S. Almaghawry Mohamed, MD · Zagazig University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-04
- Primary Completion
- 2025-09-04
- Completion
- 2025-09-04
Countries
- Egypt
Study Locations
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