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CTRI Number  CTRI/2024/11/076374 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 30/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To see if monitoring method called bispectral index, an EEG based monitor generally used for patients under anaesthesia when used along with clinical monitoring will be able to pickup early complications undergoing brain surgery. 
Scientific Title of Study   Use of Bi spectral index in conjunction with clinical neurological testing as an early warning signal to identify patients with early postoperative neurological decline following elective intracranial surgery – A prospective observational cohort study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharon kavya chandana  
Designation  DM resident 
Affiliation  CMC Vellore 
Address  Department of Neuroanaesthesiology Christian medical college Ranipet campus

Vellore
TAMIL NADU
632517
India 
Phone  09442668365  
Fax    
Email  sharonnepoldoss@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Georgene Singh 
Designation  professor 
Affiliation  CMC Vellore 
Address  Department of Neuroanaesthesiology Christian medical college Ranipet campus

Vellore
TAMIL NADU
632517
India 
Phone  944329504  
Fax    
Email  georgenesingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sharon kavya chandana  
Designation  DM resident 
Affiliation  CMC Vellore 
Address  Department of Neuroanaesthesiology Christian medical college Ranipet campus

Vellore
TAMIL NADU
632517
India 
Phone  09442668365  
Fax    
Email  sharonnepoldoss@gmail.com  
 
Source of Monetary or Material Support  
Department of Neuroanesthesia christian medical college, vellore Ranipet campus 632517  
 
Primary Sponsor  
Name  christian medical collge 
Address  cmc ranipet campus 632517 
Type of Sponsor  Private 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 
sharon kavya chanadana  Christian Medical College , Vellore  Neurosurgical wards, operation theatres, intensive care unit
Vellore
TAMIL NADU 
09442668365

sharonnepoldoss@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients coming for elective neurosurgical procedures including both supratentorial and infratentorial tumors

 
 
ExclusionCriteria 
Details  1.Patients requiring postoperative ventilation

2.Patients with traumatic brain injury

3.Patients coming for CSF diversion procedures

4.Emergency neurosurgical patients with low GCS preoperatively 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess if postoperative BIS value in the immediate postoperative period could predict early postoperative neurological
complications.

Ability of BIS to predict early postoperative neurological complications which are often preceded by decline in level of
consciousness and is comparable to GCS-P, FOUR scores. 
preop, intraop and postop upto 24 hours BIS is montitored 
 
Secondary Outcome  
Outcome  TimePoints 
To assess if BIS is comparable to GCS-P score, FOUR score in the immediate postoperative period (up to 24 hours) in predicting
early postoperative neurological complications.

To assess the association of time taken to attain preoperative baseline BIS value with various parameters like

Early postoperative complications

Length of ICU stay

Length of hospital stay

ICU readmission

Reoperation

Death 
upto 3 days postoperatively , we look for neurological complications 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   10/11/2024 
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="0"
Months="6"
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  

Neurosurgical patients are at increased risk of complications which increases morbidity and mortality. Early diagnosis helps in the reduction of future insults and facilitates early intervention and decreased postoperative morbidity. In post anaesthesia care unit, GCS and vital signs are monitored for early detection of potential complications.
Extubation of neurosurgical patients is determined by preop condition, intraoperative course, adequacy of hemostasis, blood loss, haemodynamic stability and duration of surgery. Even though GCS is a time-tested tool well validated and used worldwide for neurological assessment, its utility in the immediate postop period is debatable due to anaesthetic residual effects, interobserver variability and lack of continuous monitoring. Depth of anaesthesia monitoring has evolved to a significant extent and anaesthetic administration is totally guided by processed EEG monitors like BIS, sedline and Entropy.
BIS and GCS synchrony have been extensively studied in neurotrauma procedures evaluation of GCS is difficult. 
we propose that BIS a processed EEG monitor could detect changes in consciousness in the postoperative period. and thus aid in the prediction of neurological decline.
In our study, we would like to determine if postoperative BIS monitoring is comparable to standard neurological assessment in predicting complications.
 
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