| 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
|
|
|
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
|
|
|
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. |
|
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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. |