FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065407 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to determine the role of stellate ganglion block in prevention of cerebral vasospasm in aneurysmal subarachnoid haemorrhage patients. 
Scientific Title of Study   A prospective randomized study to determine the effect of perioperative stellate ganglion block on cerebral vasospasm in aneurysmal subarachnoid haemorrhage patients. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajat Chauhan 
Designation  Senior Resident 
Affiliation  All India Institute of medical Sciences, New Delhi 
Address  Department of Neuroanaesthesiology and Critical Care 6th floor Neurosciences centre AIIMS New Delhi South DELHI 110029 India

South
DELHI
110029
India 
Phone  9599591845  
Fax    
Email  rajat3rajat@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Sokhal 
Designation  Associate Professor 
Affiliation  All India Institute of medical Sciences, New Delhi 
Address  Department of Neuroanaesthesiology and Critical Care 6th floor Neurosciences centre AIIMS New Delhi South DELHI 110029 India

South
DELHI
110029
India 
Phone  8700330755  
Fax    
Email  sumansokhal82@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suman Sokhal 
Designation  Associate Professor 
Affiliation  All India Institute of medical Sciences, New Delhi 
Address  Department of Neuroanaesthesiology and Critical Care 6th floor Neurosciences centre AIIMS New Delhi South DELHI 110029 India

South
DELHI
110029
India 
Phone  8700330755  
Fax    
Email  sumansokhal82@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Department of Neuroanaesthesiology and Critical Care 6th floor Neurosciences centre AIIMS New Delhi South DELHI India New Delhi DELHI 110029 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
All India Institute of Medical Sciences New Delhi  Department of Neuroanaesthesiology and Critical Care,AIIMS,Ansari Nagar East, New Delhi, Delhi, 110029  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajat Chauhan  All India Institute of Medical Sciences New Delhi  Department of Neuroanaesthesiology and Critical Care 6th floor Neurosciences centre AIIMS New Delhi South DELHI India New Delhi DELHI 110029
South
DELHI 		 9599591845

rajat3rajat@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nSGB GROUP  In nSGB group standard treatment as given to any ASAH patient would be administered. The difference in treatment from SGB Group is that the perioperative stellate ganglion block will not be administered to patients in this group 
Intervention  SGB groub  After routine disinfection and preparation of the block site, under ultrasound guidance 10 mL of 0.375% ropivacaine will be injected into the surface of the longus colli muscle on the medial side of the prevertebral fascia at the level of the C6 anterior tubercle after confirming negative aspiration of blood. The puncture point will be covered with sterile dressings. The success criterion of SGB is horner’s syndrome, which is characterised by miosis, ptosis, and conjunctival hyperaemia and increase in skin temperature on the ipsilateral side of face. ROUTE OF ADMINISTRATION-Intramuscular near the stellate ganglion. FREQUENCY OF ADMINISTRATION- Preoperatively on the day of surgery and on the First Day after Surgery. Only two Stellate ganglion block are administered. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  18 years to 65 years,
Anterior circulation aneurysms,
Planned aneurysm clipping,
Pre operative Hunt and Hess grade I II and III

 
 
ExclusionCriteria 
Details  ASA physical status more than III
Posterior circulation aneurysm
Multiple aneurysms
Allergy to known local anaesthetics
Pregnant women
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OUTCOME - To compare the incidence of TCD defined cerebral vasospasm MCA or ACA velocity more than 120cm per second in patients receiving perioperative Stellate Ganglion Block versus standard treatment group which is the control group here.  TCD will be used to measure cerebral blood flow velocity in MCA or ACA preoperatively day 0 and after surgery on day 1,2,3,5 and 7th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of symptomatic cerebral vasospasm within 14 days after aSAH
Any additional intervention done for cerebral vasospasm
Peri operative complications
Total length of stay in the ICU and hospital
Functional outcome at 3 months
 		 Till discharge from hospital 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 4 
Date of First Enrollment (India)   01/05/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rajat3rajat@yahoo.co.in].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 28-07-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Patients will be enrolled based on the following inclusion and exclusion criteria. Patients with aSAH diagnosed by imaging (CTA or DSA) and scheduled for surgical intervention within the time period of 72h after ictus will be assessed for recruitment.All TCD measurements would be performed by another observer who would be blinded to the intervention received in the patients. TCD will be monitored by VIASONIX Dolphin/4D model by Viasonix Ltd, Israel. TCD monitoring will be performed before surgery (T0) baseline and on the subsequent post operative days, 1st (T1), 2nd (T2), 3rd (T3), 5th (T4) and 7th (T5) after the operation or earlier if discharged from ICU before 7 days. The incidence of complications, including myocardial infarction, postoperative rebleeding, moderate and severe brain oedema, pulmonary embolism, deep venous thrombosis, SGB-related complications, unexpected adverse events and intra operative complications will also be recorded. 
Close