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CTRI Number  CTRI/2019/04/018516 [Registered on: 09/04/2019] Trial Registered Prospectively
Last Modified On: 08/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To study effect of stellate ganglion block on electrical activity of heart in patients having recent bleeding beneath innermost membrane around brain with constriction in arteries supplying brain- A preliminary study based on Holter monitoring. 
Scientific Title of Study   Effect of stellate ganglion block on cardiac rhythm in patients with acute aneurysmal sub-arachnoid hemorrhage with vasospasm: a holter-based preliminary study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandrakant Prasad 
Designation  Senior Resident ( Academic) 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Neuro-anasethesiology & Critical Care, All India Institute of Medical Sciences, Ansarinagar, New Delhi.

South
DELHI
110029
India 
Phone  9572598662  
Fax    
Email  chandrakant.rims07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra S Chouhan 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Neuro-anasethesiology & Critical Care, All India Institute of Medical Sciences, Ansarinagar, New Delhi.

South
DELHI
110029
India 
Phone  9667808169  
Fax    
Email  drrajendrasinghchouhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandrakant Prasad 
Designation  Senior Resident ( Academic) 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Neuro-anasethesiology & Critical Care, All India Institute of Medical Sciences, Ansarinagar, New Delhi.

South
DELHI
110029
India 
Phone  9572598662  
Fax    
Email  chandrakant.rims07@gmail.com  
 
Source of Monetary or Material Support  
Department of Neuro-anasethesiology & Critical Care, All India Institute of Medical Sciences, Ansarinagar, New Delhi. 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansarinagar, New Delhi- 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandrakant Prasad  All India Institute of Medical Sciences  Neurosurgery intensive Care Unit C, 1st floor, Cardio-thoracic & Neuroscience centre.
South
DELHI 		 9572598662

chandrakant.rims07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Istitutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Stellate Ganglion Block  Using all aseptic precautions, stellate ganglion block (SGB) will be performed using 7 ml bupivacaine (0.25%) by anterior paratracheal approach at C6 level under ultrasonographic guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patients aged 18-65 years belonging to either sex, requiring stellate ganglion block for treatment of clinical cerebral vasospasm after undergoing microsurgical clipping of cerebral aneurysm will be studied. 
 
ExclusionCriteria 
Details  Refusal of consent, patients with multiple aneurysms and having an unsecured aneurysm, history of allergy to local anaesthetics, disturbed coagulation profile and patient with preexisting pupillary changes where assessment of effectiveness of stellate ganglion block (SGB) would be difficult. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
effects of stellate ganglion block (SGB) used for treatment of cerebral vasospasm following acute aneurysmal subarachnoid haemorrhage (aSAH) on cardiac rhythm with Holter monitoring.  24 hours after stellate ganglion block 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study hemodynamic parameters after stellate ganglion block (SGB) for treatment of cerebral vasospasm following acute aneurysmal subarachnoid haemorrhage (aSAH).

2.To study neurological outcome after treatment of cerebral vasospasm with stellate ganglion block (SGB) following acute aneurysmal subarachnoid haemorrhage (aSAH).
 		 Hemodynamic parameters will be recorded 1 hourly.
Neurological outcome will be assessed after 3 months. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1.Jain V, Rath G P, Dash H H, Bithal P K, Chouhan R S. Stellate ganglion block for treatment of cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage – A preliminary study. J Anaesthesiol Clin Pharmacol 2011; 27: 516-521 2.Di Pasquale G, Pinelli G, Andreoli A, Manini GL, Grazi P, Tognetti F. Holter detection of cardiac arrhythmias in intracranial subarachnoid hemorrhage. Am J Cardiol 1987; 59: 596–600. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Use of SGB been reported for the management of cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH).Treggiari and colleagues (2003) suggested use of superior cervical sympathetic block to relieve cerebral vasospasm in patients with subarachnoid hemorrhage (SAH) and demonstrated improved cerebral perfusion without change in vessel diameter at cerebral angiography. Subarachnoid hemorrhage (SAH) has long been known to be associated with abnormalities of ‘R’ and ‘T’ waves, S-T segment changes and presence of ‘U’ waves in the electrocardiogram.In addition, cardiac rhythm abnormalities in the form of sinus bradycardia and sinus tachycardia, wandering atrial pacemaker and atrial fibrillation are also commonly encountered after aneurysmal SAH. Di Pasquale and co-researchers (1987) performed holter monitoring in subarachnoid hemorrhage patients up to about 72 hours after ictus and reported arrhythmias in 96 (90%) of the 107 patients.However, a recent study reported that about 8% patients with SAH had an arrhythmia sometime during their hospital stay. Half of these arrhythmias were clinically significant and developed a median of 3 days after ictus. Efforts have been made to study effects of modulating sympathetic supply to the heart through stellate ganglion block, though not in patients suffering from aSAH, but the results are not clear. Malik and associates (2014) reported percutaneous inferior cervical sympathetic ganglion blockade effective  for the treatment of ventricular tachycardia storm.Efforts have been made to study effects of modulating sympathetic supply to the heart through stellate ganglion block, though not in patients suffering from aSAH, but the results are not clear.Malik and associates (2014) reported percutaneous inferior cervical sympathetic ganglion blockade effective  for the treatment of ventricular tachycardia storm. Chen and colleagues (2015), reported protective effect of SGB on the myocardium and suppression of stress responses during anesthetic induction and tracheal intubation.

We hypothesize that SGB can reduce incidence of cardiac arrythmias in patients with aSAH.

 At the All India Institute of Medical Sciences, about 150 patients are admitted with aneurysmal subarachnoid hemorrhage (aSAH) annually and two thirds of these undergo surgical clipping. During the postoperative course, in several of these patients stellate ganglion block is performed for the management of symptomatic cerebral vasospasm.
Till date, effect of SGB on cardiac rhythm has not been studied in patients with aneurysmal SAH, therefore, we planned to prospectively study effect of SGB on cardiac rhythm with holter monitoring in patients suffering from cerebral vasospasm following acute aneurysmal SAH.

 Primary objective 

 To study effects of stellate ganglion block (SGB) used for treatment of cerebral vasospasm following acute aneurysmal subarachnoid hemorrhage (aSAH) on cardiac rhythm with Holter monitoring.
 Secondary objectives
ØTo study hemodynamic parameters after stellate ganglion block (SGB) for treatment of cerebral vasospasm following acute aneurysmal subarachnoid hemorrhage (aSAH).

ØTo study neurological outcome after treatment of cerebral vasospasm with stellate ganglion block (SGB) following acute aneurysmal subarachnoid hemorrhage (aSAH).
 
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