Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354673
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-10
First Post:
2024-04-04
Brief Title:
Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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 patientsAlternative 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 patientswhich 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
Detailed Description:
PATIENTS AND METHODS
I Technical Design
1 Site of study
This study will be carried out in the emergency intensive Care unit ICU of Zagazig University Hospitals within 6 months
2 Sample size
The sample size was collected using G power version 3197 according to the following expected moderate effect size between stellate ganglion plus dexmedetomidine group SD group and stellate ganglion block plus ketamine group SK group d05 CI 95 and power 80 the sample size was calculated to be 10251 in each group
3 Patients included in this study
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 al2 The signs of PAID syndrome include 1 Severe brain injury Rancho Los Amigos level IV 2 temperature of at least 385C 3 pulse of at least 130 beatsmin 4 respiratory rate of at least 140 breathsmin 5 agitation 6 diaphoresis and 7 dystonia ie rigidity or decerebrate posturing The duration is at least1 cycleday 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 three months
7 Patients complicated with a history of end stage malignancy
8 Patients complicated with a history of uncontrolled epilepsy
Withdrawal criteria
The patient has the right to withdraw from the study at any time without any negative consequence on their medical treatment plan
II Operational Design
1 Type of study
Double-blinded randomized clinical trial
2 Parameters of the study will include
All patients suspected of having PSH will underwent detailed clinical history and physical examination Hemodynamics monitoring including heart rate and mean arterial pressure MAP also temperature monitoring will be done as base line before the block and after stellate ganglion block every one hour over 24 hours until remission till return to normal values for age and sex These patients will be also subjected to routine hematological investigations including complete blood count kidney and liver function test coagulation profile urine analysis for myoglobinuria and thyroid profile septic screening including blood urine tracheal aspirate and sputum culture and radiological assessment by using chest x-ray
All patients developing PSH will be randomly allocated by using computerized generated randomization table into two groups
SD group Stellate ganglion block and 1 ugkgh intravenous Dexmedetomidine infusion
SK group Stellate ganglion block and 05 mgkgh intravenous ketamine infusion
Stellate ganglion block
Patients will undergo an ultrasonography-guided SGB at bedside under standard American Society of Anesthesiologists monitoring standards The patient will be placed in supine position with the head turn to the opposite side The anterior and lateral parts of the neck will be prepped with chlorhexidine and a linear 13-6 MHz ultrasound probe will be applied to the anterolateral neck at the cricoid cartilage level to identify the transverse process of C6 and C7 anterior tubercle of C6 Chassaignac tubercle longus colli muscle and surrounding neurovascular structure The needle will be advanced with an in-plane technique and aimed to deposit the local anesthetics medial to the Chassaignac tubercle and anterior to pre-vertebral fascia of longus colli muscle After that a catheter will be advanced through the needle and secured in place After aspiration 10 ml of bupivacaine 025 solution will be injected through the catheter and repeated every 48 hours till time of remission
a Data to be measured
1 Demographic data including age sex BMI ASA classification
2 Hemodynamics including MAP and heart rate and temperature measurement as base line before stellate ganglion block after stellate ganglion block and furtherly every hour over 24 hours till time of remission return to normal value for age and sex
3 Remission time of paroxysmal hypertension min time from the start of treatment till return to normal blood pressure
4 Remission time of paroxysmal tachycardia min time from the start of treatment till return to normal heart rate
5 Remission time of paroxysmal hypermyotonia day the criteria of muscle hyperactivity is the rigid posture or sever dystonia ie rigidity or decerebrate posturing
6 Remission time of decrease respiratory rate below 25 breathmin min time from the start of treatment till time of decrease respiratory rate below 25 breathmin
7 Changes in glascow coma scale score GSC from admission to ICU till discharge GSC will be evaluated once daily
8 Duration of ICU stay days the duration from the admission till discharge from ICU
I Technical Design
1 Site of study
This study will be carried out in the emergency intensive Care unit ICU of Zagazig University Hospitals within 6 months
2 Sample size
The sample size was collected using G power version 3197 according to the following expected moderate effect size between stellate ganglion plus dexmedetomidine group SD group and stellate ganglion block plus ketamine group SK group d05 CI 95 and power 80 the sample size was calculated to be 10251 in each group
3 Patients included in this study
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 al2 The signs of PAID syndrome include 1 Severe brain injury Rancho Los Amigos level IV 2 temperature of at least 385C 3 pulse of at least 130 beatsmin 4 respiratory rate of at least 140 breathsmin 5 agitation 6 diaphoresis and 7 dystonia ie rigidity or decerebrate posturing The duration is at least1 cycleday 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 three months
7 Patients complicated with a history of end stage malignancy
8 Patients complicated with a history of uncontrolled epilepsy
Withdrawal criteria
The patient has the right to withdraw from the study at any time without any negative consequence on their medical treatment plan
II Operational Design
1 Type of study
Double-blinded randomized clinical trial
2 Parameters of the study will include
All patients suspected of having PSH will underwent detailed clinical history and physical examination Hemodynamics monitoring including heart rate and mean arterial pressure MAP also temperature monitoring will be done as base line before the block and after stellate ganglion block every one hour over 24 hours until remission till return to normal values for age and sex These patients will be also subjected to routine hematological investigations including complete blood count kidney and liver function test coagulation profile urine analysis for myoglobinuria and thyroid profile septic screening including blood urine tracheal aspirate and sputum culture and radiological assessment by using chest x-ray
All patients developing PSH will be randomly allocated by using computerized generated randomization table into two groups
SD group Stellate ganglion block and 1 ugkgh intravenous Dexmedetomidine infusion
SK group Stellate ganglion block and 05 mgkgh intravenous ketamine infusion
Stellate ganglion block
Patients will undergo an ultrasonography-guided SGB at bedside under standard American Society of Anesthesiologists monitoring standards The patient will be placed in supine position with the head turn to the opposite side The anterior and lateral parts of the neck will be prepped with chlorhexidine and a linear 13-6 MHz ultrasound probe will be applied to the anterolateral neck at the cricoid cartilage level to identify the transverse process of C6 and C7 anterior tubercle of C6 Chassaignac tubercle longus colli muscle and surrounding neurovascular structure The needle will be advanced with an in-plane technique and aimed to deposit the local anesthetics medial to the Chassaignac tubercle and anterior to pre-vertebral fascia of longus colli muscle After that a catheter will be advanced through the needle and secured in place After aspiration 10 ml of bupivacaine 025 solution will be injected through the catheter and repeated every 48 hours till time of remission
a Data to be measured
1 Demographic data including age sex BMI ASA classification
2 Hemodynamics including MAP and heart rate and temperature measurement as base line before stellate ganglion block after stellate ganglion block and furtherly every hour over 24 hours till time of remission return to normal value for age and sex
3 Remission time of paroxysmal hypertension min time from the start of treatment till return to normal blood pressure
4 Remission time of paroxysmal tachycardia min time from the start of treatment till return to normal heart rate
5 Remission time of paroxysmal hypermyotonia day the criteria of muscle hyperactivity is the rigid posture or sever dystonia ie rigidity or decerebrate posturing
6 Remission time of decrease respiratory rate below 25 breathmin min time from the start of treatment till time of decrease respiratory rate below 25 breathmin
7 Changes in glascow coma scale score GSC from admission to ICU till discharge GSC will be evaluated once daily
8 Duration of ICU stay days the duration from the admission till discharge from ICU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None