| CTRI Number |
CTRI/2024/11/077275 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Data collection study |
| Study Design |
Other |
|
Public Title of Study
|
Collection of EEG recordings in patients under general anesthesia |
|
Scientific Title of Study
|
A prospective observational study to collect EEG recordings of hospitalized patients prior and during elective surgery under general anesthesia |
| Trial Acronym |
EEG recordings study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BGU/SSC/2024 V1.0 17JUL2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudheesh K |
| Designation |
Prof and HoD of Aneshtesiology |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Room 47, B Block
Bangalore
KARNATAKA
560002
India |
| Phone |
9900134694 |
| Fax |
|
| Email |
dr.sudhi77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Suresh Kumar |
| Designation |
Director Clinical Development |
| Affiliation |
SunSecure Clinical Research Services Pvt Ltd |
| Address |
Room 110, DS Max Savvy, Anjanapura
Bangalore
KARNATAKA
560062
India |
| Phone |
9739798272 |
| Fax |
|
| Email |
dr.suresh.karri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sravani P S L |
| Designation |
Founder and Director |
| Affiliation |
SunSecure Clinical Research Services Pvt Ltd |
| Address |
Amruth Nagar Main Road, Anjanapura Post
Bangalore
KARNATAKA
560062
India |
| Phone |
9611293347 |
| Fax |
|
| Email |
sravani@sunsecure.co.in |
|
|
Source of Monetary or Material Support
|
| Ben Gurion University of the Negev BGU, David Ben Gurion Blvd 1, Beer Sheva, Israel - 84105 |
|
|
Primary Sponsor
|
| Name |
Ben Gurion University of the Negev BGU |
| Address |
Ben Gurion University of the Negev BGU, David Ben Gurion Blvd 1, Beer Sheva, Israel - 84105 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudheesh K |
Bangalore Medical College and Research Institute - Victoria Hospital |
Room 47, B Block, Dept. of Orthopaedics
Bangalore
KARNATAKA |
09900134694
dr.sudhi77@gmail.com |
| Dr Prashanth Prabhu |
Sapthagiri Institute of Medical Sciences and Research Center |
Dept. of Clinical Research, Room 18
Bangalore
KARNATAKA |
09035067161
gm@sapthagiriclintrac.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee BMCRI |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 to 65 years (both inclusive)
2. Both male and female
3. Patients hospitalized for elective surgery under general
anaesthesia
4. General anaesthesia classified as ASA 1 to 2 in the pre anaesthesia examination |
|
| ExclusionCriteria |
| Details |
1. Any injury or damage to the scalp or skull
2. Refusal or unwillingness to participate in the study
3. Use of medications such as beta-blockers that can affect heart rate and blood pressure.
4. Patients with a history of demyelinating disease or any progressive neurological disorder
5. Patient data with an active infection of the central nervous system, severe acute or chronic disease (haematological, renal, cancer, acquired immunodeficiency syndrome)
6. Patients with impaired consciousness from various reasons |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of EEG recordings with the level of consciousness in patients under general anaesthesia and develop a tool |
EEG data including 5 min of baseline activity before anaesthesia and 1-3 hours of recording during anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Medications during recording/ hospitalization from the medical record in hospitalization
â— Reason for monitoring (presurgical, diagnosis)
â— Comorbidities |
5 min of baseline activity before anaesthesia and 1-3 hours of recording during anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Defining the level of consciousness in a patient under full anaesthesia poses a challenge. Despite advancements in EEG technology and scientific knowledge, no device is available to accurately determine the depth of anaesthesia required for surgery. This results in inaccuracies when assessing the patient’s consciousness during the procedure. Metrics such as blood pressure or bispectral index fall short in characterizing consciousness levels, as they cannot entirely prevent instances of wakefulness or a certain level of consciousness during surgery. Thus, there is a need for a more precise tool to evaluate such situations. We want to develop a diagnostic tool that can consistently determine the patient’s level of consciousness, independently of subjective interpretations and across different individuals. |