| CTRI Number |
CTRI/2025/09/094482 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Bi spectral Index Electrode Placements at Frontal–Mandibular and Frontal–Postauricular sites with an intergroup and an intra group analysis for signal superiority in ASA I and II Adult neurosurgery patients |
|
Scientific Title of Study
|
Analyzing bispectral index electrode placement: Comparisons between frontal and mandibular v/s frontal and postauricular locations, followed by intergroup analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Fotedar |
| Designation |
DrNB Trainee |
| Affiliation |
Artemis Health Institute |
| Address |
Department of Neuroanesthesia, Artemis Health Institute, Gurugram, Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
01244511111 |
| Fax |
|
| Email |
dr.shivani.fotedar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivani Fotedar |
| Designation |
DrNB Trainee |
| Affiliation |
Artemis Health Institute |
| Address |
Department of Neuroanesthesia, Artemis Health Institute, Gurugram, Haryana
HARYANA
122001
India |
| Phone |
01244511111 |
| Fax |
|
| Email |
dr.shivani.fotedar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Fotedar |
| Designation |
DrNB Trainee |
| Affiliation |
Artemis Health Institute |
| Address |
Department of Neuroanesthesia, Artemis Health Institute, Gurugram, Haryana
HARYANA
122001
India |
| Phone |
01244511111 |
| Fax |
|
| Email |
dr.shivani.fotedar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Artemis Health Institute |
| Address |
Sector 51, Gurugram, Bindapur, Haryana 122001
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Ashish Chakravarty |
Artemis Health Institute |
Sector 51, Gurugram, Bindapur, Haryana 122001
Gurgaon
HARYANA |
9873766104
drashishin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Frontal electrode |
The frontal electrode will act as a standard comparator for BIS electrode comparison |
| Intervention |
Mandibular electrode |
The mandibular electrode will be placed in the described position and compared with the frontal electrode |
| Intervention |
Post auricular electrode |
The post auricular electrode will be compared with the standard frontal electrode |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 and above and below 65 yrs
2. ASA physical status I or II
3. Scheduled for various neurosurgical , cranial and spinal procedures |
|
| ExclusionCriteria |
| Details |
1. Presence of skin lesions or scars at potential sensor sites that could impede sensor placement or
function.
2. Allergies: Known hypersensitivity to adhesives or materials used in BIS sensors.
3. Bearded individuals for mandibular placement of electrodes
4. GCS less than 15 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary aim of this study is to evaluate the validity of alternative placements of the Bispectral Index
sensor—specifically the mandibular and post auricular positions—compared to the traditional frontal
placement, in measuring the depth of anesthesia during surgical procedures.
|
The time points would be the following
1. Baseline
2. 90 seconds after administration of fentanyl and propofol
3. 3 mins after giving muscle relaxant
4. At intubation
5. At the time of first pain stimulus
6. Every 30 s into the procedure
7. At extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Practicality of Sensor
Placement: Evaluate the practicality of each sensor placement in terms of
ease of application, stability of the sensor during operation, & incidence of needing to reposition
the sensor.
Impact on Clinical Decision-Making: Investigate whether the sensor placement impacts clinical
decision-making, particularly decisions regarding adjustments in anesthetic dosage based on BIS
readings & arrive at recommendations. |
Baseline
2. 90 seconds after administration of fentanyl & propofol
3. 3 mins after giving muscle relaxant
4. At intubation
5. At the time of first pain stimulus
6. Every 30 s into the procedure
7. At extubation |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
30/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2025 |
| 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 Yet Recruiting |
| 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
|
Introduction The Bispectral Index is a widely used tool for monitoring the depth of anesthesia, derived from electroencephalography (EEG) signal analysis. Accurate BIS readings are crucial for optimal anesthetic management. Traditional frontal electrode placement is sometimes impractical, necessitating exploration of alternative placements. Objective To compare the accuracy and reliability of BIS readings from frontal, mandibular, and frontal post-auricular electrode placements and conduct inter-group analysis to determine the most effective alternative to the frontal placement. Methods
Study Design: A prospective, comparative observational study.
Participants: 130 patients undergoing neurosurgeries with neuro anesthesia, randomized into two groups (65 per group) based on electrode placement: frontal, mandibular, and frontal , post- auricular.
Data Collection: BIS readings, signal quality index (SQI), and electromyography (EMG) scores were recorded at six stages: pre-anesthesia, induction, muscle relaxation maintenance, closure, and extubation.
Analysis: Statistical methods will be used to compare BIS values, SQI, and EMG scores across different placements and between groups. Correlation coefficients will be assessed with the agreement between frontal and alternative placements.
Keywords: Bispectral Index, BIS, electrode placement, anesthesia monitoring, EEG, frontal, mandibular, post-auricular, patient safety. |