| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, |
|
|
Intervention / Comparator Agent
|
|
|
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. |