Clinical trial

Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm After Traumatic Brain Injury in Critically Ill Patients: A Randomized Clinical Study.

Name
278/1-April-2024
Description
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.
Trial arms
Trial start
2024-04-04
Estimated PCD
2024-09-04
Trial end
2024-10-04
Treatment
Stellate ganglion block
Sympathectomy by using combination of regional nerve block and systemic drugs
Arms:
SD group, SK group
Dexmedetomidine
intravenous Dexmedetomidine infusion
Arms:
SD group
Other names:
Precedex
Ketamine
intravenous ketamine infusion
Arms:
SK group
Size
205
Primary endpoint
To compare the time of remission of neurostorm symptoms
6 months
To assess effect of stellate ganglion block combined with either dexmedetomidine or subanesthetic ketamine infusion on changes in glascow coma scale score.
6 months
Eligibility criteria
Inclusion Criteria: 1. Written informed consent from 1st degree relative. 2. Physical ASA status I \& II. 3. BMI less than or equal 35. 4. Traumatic brain injury patients. 5. Age: ≥18 years old. 6. Sex: both sexes. 7. 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 Exclusion Criteria: * 1) 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. 6) 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. 8) Patients complicated with a history of uncontrolled epilepsy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 205, 'type': 'ESTIMATED'}}
Updated at
2024-04-10

1 organization

1 product

1 drug

1 indication

Organization
Zagazig University