| CTRI Number |
CTRI/2025/12/099588 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
We will compare BIS scores, which is a number that determines depth of anaesthesia, from different electrode placement- one strip over forehead and the other above upper lip in head and spine surgeries |
|
Scientific Title of Study
|
Comparison of BIS scores derived from frontal lead placement and supralabial lead placement in neurosurgical patient under general anaesthesia -A one year hospital based cross sectional 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 |
Dr Mahantesh S Mudakangoudar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
7829164500 |
| Fax |
|
| Email |
drmontygoudar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahantesh S Mudakangoudar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
7829164500 |
| Fax |
|
| Email |
drmontygoudar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahantesh S Mudakangoudar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
7829164500 |
| Fax |
|
| Email |
drmontygoudar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical
Primary Sponsor College, Nehru Nagar, Belagavi, Karnataka. India. Pincode-590010 |
|
|
Primary Sponsor
|
| Name |
Dr Shama V Bevinagidad |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum 590010
Karnataka
India |
| 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 |
| Dr Shama V Bevinagidad |
KLE hospital |
Department of anaesthesiology
Nehru Nagar
Belgavi
Belgaum
KARNATAKA |
8095404660
shama2101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi-590010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing neurosurgery
ASA status I and II
Provides consent |
|
| ExclusionCriteria |
| Details |
ASA status of III, IV, V and VI
Facial deformities
History of disabling central nervous or cerebrovascular disease
Currently taking central nervous system active drugs or psychiatric medication
Patients who do not fulfill inclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of BIS scores derived from frontal lead placement and supralabial lead placement in neurosurgery patients under general anaesthesia |
Every 30 mins throughout the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
31/12/2025 |
| 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
Modification(s)
|
Years="1"
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
|
Two BIS Quatro sensors , one strip is attached to the standard site, that is frontal and and the other one to the study site- supralabial region of the patient. Frontal sensors will be applied with circle 1 at the center of the forehead; circle 2, 2.8 cm lateral to circle 1; and circle 3 on either temporal area between the corner of the eye and the hairline. For the Supralabial site, such that electrode 1 at the philtrum, electrode 4 on the maxilla and electrode 3 on the temporal area near electrode 3 of the standard strip. These sensors are connected to the monitor alternatively every 30 minutes and values are recorded and hemodynamics noted |