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CTRI Number  CTRI/2024/09/074193 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Brain biological response during brain surgery and its effect on cognition and sleep 
Scientific Title of Study   Role of neuroinflammation on postoperative neurocognitive disorders in neurosurgical patients: A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeetha RP 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical care, Third floor, Faculty block, NIMHANS, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  9480829770  
Fax    
Email  sangeetharp14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sangeetha RP 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical care, Third floor, Faculty block, NIMHANS, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  9480829770  
Fax    
Email  sangeetharp14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sangeetha RP 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical care, Third floor, Faculty block, NIMHANS, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone    
Fax    
Email  sangeetharp14@gmail.com  
 
Source of Monetary or Material Support  
Nimhans Institute Intramural Research Scheme, National Institute of Mental Health and Neurosciences, Hosur road, Bangalore 
 
Primary Sponsor  
Name  National Institute of Mental health and Neurosciences 
Address  Hosur road, Bangalore 
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 
Dr Sangeetha Rp  National Institute of Mental Health and Neurosciences  Operating theatres of National Institute of Mental Health and Neurosciences, Hosur road, Bangalore
Bangalore
KARNATAKA 		 9480829770

sangeetharp14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D332||Benign neoplasm of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL as it is an observational study   NIL as it is an observational study  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult consenting patients undergoing elective tumour resection surgeries and spinal cord surgeries 
 
ExclusionCriteria 
Details  Patients below 18 years of age, refusal of consent, awake and emergency surgeries 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to compare the preoperative (pre surgical incision) and postoperative (at 24 hours postoperative) neuroinflammatory markers in elective brain and spine surgeries  Preoperative (pre surgical incision) and postoperative (at 24 hours postoperative) neuroinflammatory markers [IL-33, Neurofilament light chain (Nf-L) and MMP 9] in elective brain and spine surgeries 
 
Secondary Outcome  
Outcome  TimePoints 
correlation between pre-post change in neuroinflammatory markers and incidence of post-opertaive delirium (POD), Delayed cognitive neurocognitive recovery (DCNR), and postoperative neurocognitive dysfunction (PND) at 6 months after cranial and spinal surgeries.  Montreal Cognitive Assessment (MOCA) (Annexure-1) will be used to assess baseline neurocognitive disorder (NCD) and POD between the 2nd -3rd, and 5th -7th postoperative day or at the time of discharge, whichever is earlier. 
to study the relationship between sleep, inflammation and POD  Assessment of sleep quality using the Richard Campbell sleep questionnaire (RCBSQ) will be done in the pre-operative period and between the 2nd -3rd, and 5th -7th postoperative day or at the time of discharge, whichever is earlier 
to study the relationship between pain, inflammation and POD  Assessment of pain using the Visual Analogue Scale (VAS) score will be done in the pre-operative period and between the 2nd -3rd, and 5th -7th postoperative day or at the time of discharge, whichever is earlier. 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   30/09/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Delirium after surgery occurs in 10% to 60% of elderly postoperative patients. A metanalysis of 5589 patients who underwent intracranial surgery showed an incidence of POD ranging from 12 to 26% due to variation in clinical features and delirium assessment methods Most of these studies excluded patients with pre-existing cognitive dysfunction. Also, the representation of spinal surgeries in studies describing the incidence of POCD in non-cardiac surgeries is extremely small. There are no exclusive studies mentioning the incidence of POCD in spinal surgeries. An important risk factor for the development of PND is neuroinflammation.
The aim of this study is to study the neuroinflammatory changes in cranial and spinal surgeries and their association with occurrence of POD
Our primary objective is to compare the difference in the preoperative and postoperative neuroinflammatory markers during elective brain and spine surgeries in adult patients (study population).
Our secondary objectives are to evaluate if the difference in the degree of neuroinflammation between cranial and spinal surgeries affects the incidence of POD, DNCR, and PND at 1 and 6 months, respectively after surgery. We also intend to study the relationship of pain and sleep quality with inflammation and cognition among these patients.
 
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