FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074029 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 12/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessment of the brains blood supply reserve and its relation to postoperative clinical outcome in patients undergoing brain tumour surgery 
Scientific Title of Study   Assessment of cerebrovascular reserve and clinical outcomes after elective supratentorial tumour surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Protiti Chatterjee 
Designation  Senior Resident 
Affiliation  National Institute of Mental Health & Neurosciences 
Address  Department of Neuroanaesthesia & Neurocritical Care, National Institute of Mental Health & Neurosciences, Hosur Road, Hombegowda Nagar, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  8910362422  
Fax    
Email  protitichatterjee2016@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramesh VJ 
Designation  Professor 
Affiliation  National Institute of Mental Health & Neurosciences 
Address  Department of Neuroanaesthesia & Neurocritical Care, National Institute of Mental Health & Neurosciences, Hosur Road, Hombegowda Nagar, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9844432607  
Fax    
Email  drvjramesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ramesh VJ 
Designation  Professor 
Affiliation  National Institute of Mental Health & Neurosciences 
Address  Department of Neuroanaesthesia & Neurocritical Care, National Institute of Mental Health & Neurosciences, Hosur Road, Hombegowda Nagar, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9844432607  
Fax    
Email  drvjramesh@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health & Neurosciences (NIMHANS), Hosur Road, Bengaluru 560029, Karnataka, India 
 
Primary Sponsor  
Name  NIMHANS 
Address  Department of Neuroanaesthesia & Neurocritical Care, National Institute of Mental Health & Neurosciences (NIMHANS) 
Type of Sponsor  Research institution and hospital 
 
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 
Protiti Chatterjee  National Institute of Mental Health & Neurosciences (NIMHANS)  Pre-operative patient holding area, Neurocenter Building 2nd floor, Department of Neuroanesthesia and Neurocritical Care. Hosur Road, Hombegowda Nagar, Bengaluru 560029, Karnataka, India
Bangalore
KARNATAKA 
8910362422

protitichatterjee2016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria incudes al adult males and females aged between 50 and 80 years undergoing elective supratentorial tumour surgery at NIMHANS 
 
ExclusionCriteria 
Details  1.absent transtemporal transcranial doppler window
2.patients not co-operating for transcranial doppler examination
3.unable to hold breath for atleast 15 seconds 4.undergoing endoscopic pituitary surgery, awake craniotomy, epilepsy surgery
5.loss to follow up at 3 months
6.absence of written informed consent
7.glasgow coma score less than 15 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess pre-operative cerebrovascular reserve by breath holding index in patients undergoing elective supratentorial tumour surgeries and comparing it with the post-operative neurological deficits. (new onset as well as worsening of pre-existing neurological deficits).   1.Breath holding index at pre-operative period and at 3 months follow up.
2.Neurological examination at pre-operative period, at discharge, and 3 months follow up. 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the post-operative neurological deficits (new onset, as well as worsening of pre-existing neurological deficits) to the preoperative autonomic dysfunction  1.Neurological examination at pre-operative period, at discharge and at 3 months follow up.
2.Autonomic dysfunction at pre-operative period 
To assess changes in cerebrovascular reserve at 3 months after surgery and its comparison to pre-operative status  1.Cerebrovascular reserve assessment at pre-operative period, and at 3 months follow-up. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   23/09/2024 
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="2"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Intracranial tumors often impair cerebral autoregulation, especially in the regions adjacent to the tumors. This impairment can affect the brain’s ability to regulate blood flow in response to increased metabolic demand or stimuli, a capacity known as cerebrovascular reserve. Previous studies have shown that this reserve is often compromised in patients with supratentorial tumors. While some research has explored the immediate effects of tumor decompression on cerebrovascular reserve, there is limited data on long-term outcomes and the potential link between impaired reserve and postoperative neurological deficits. This study investigates the relationship between preoperative cerebrovascular reserve and postoperative neurological deficits in patients undergoing elective supratentorial brain tumor surgeries. The study hypothesizes that patients with impaired preoperative cerebrovascular reserve are more likely to develop new or worsening postoperative neurological deficits. The aim is to assess preoperative cerebrovascular reserve and correlate it with the incidence of postoperative neurological deficits. Additionally, the study will examine the relationship between preoperative autonomic dysfunction and postoperative outcomes, as well as changes in cerebrovascular reserve three months after surgery. This prospective observational study will be conducted at the National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, involving adult patients aged 50 to 80 years undergoing elective supratentorial tumor surgeries. The cerebrovascular reserve will be assessed by calculating the Breath Holding Index (BHI) using Transcranial Doppler (TCD). Autonomic function will be assessed from measuring the patient’s heart rate variability in the pre-operative period. The results from this study will provide valuable insights into the impact of impaired cerebrovascular reserve on postoperative neurological outcomes and the potential role of autonomic dysfunction in these patients.

 
Close