| CTRI Number |
CTRI/2025/10/095983 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective crossover study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of head-down position on brain activity in patients undergoing surgery under general anaesthesia. |
|
Scientific Title of Study
|
Effect of trendelenburg position on bispectral index in patients undergoing surgery under general anaesthesia - a prospective crossover 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 Harshitha bhargav N |
| Designation |
MD anaesthesiology and pain relief |
| Affiliation |
Kidwai memorial institute of oncology. |
| Address |
No.2363 , 2nd A main road , 2nd cross , vivekanandanagar , Bangarpet , Kolar didtrict.
No.750,Booravalli,7th Cross HBCS, Kempegowda BSK 3rd Stage Kathriguppe
Kolar
KARNATAKA
563114
India |
| Phone |
9972017658 |
| Fax |
|
| Email |
harshithabhargavhbn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arathi B H |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Kidwai memorial institute of oncology. |
| Address |
Dr. M H Marigowda road ,Lakkasandra ,Hombegowda Nagar,
Bengaluru,Karnataka.
Bangalore
KARNATAKA
560029
India |
| Phone |
9845285207 |
| Fax |
|
| Email |
arathibh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arathi B H |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Kidwai memorial institute of oncology. |
| Address |
Dr. M H Marigowda road ,Lakkasandra ,Hombegowda Nagar,
Bengaluru,Karnataka.
Bangalore
KARNATAKA
560029
India |
| Phone |
9845285207 |
| Fax |
|
| Email |
arathibh@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY BANGALORE |
|
|
Primary Sponsor
|
| Name |
DR HARSHITHA BHARGAV N |
| Address |
No.2363,2nd A MAIN ,2ND CROSS,VIVEKANANDANAGAR , BANGARPET,KOLAR,KARNATAKA,563114 |
| Type of Sponsor |
Other [SELF] |
|
|
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 HARSHITHA BHARGAV N |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY BANGLORE |
DEPARTMENT OF ANESTHESIOLOGY AND PAIN RELIEF OT BLOCK KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
DR M H MARIGOWDA ROAD BANGALORE 560029
Bangalore
KARNATAKA |
9972017658
harshithabhargavhbn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTEE,KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient belonging to ASA grade 1-2
2.Patient consenting to the procedure |
|
| ExclusionCriteria |
| Details |
1.Patients with a history of neurological disease , a previous history of head injury , glaucoma and patients with uncontrolled hypertension.
2. Patients with history or allergy or contraindication to any anaesthetic drug .
3.Patients not consenting to the procedure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Trendelenburg position on bispectral index in patients undergoing surgery under general anaesthesia. |
5 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Trendelenburg position on Systolic blood pressure, diastolic blood pressure, Mean arterial pressure, heart rate. |
5 minutes. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/10/2025 |
| 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
|
Years="2"
Months="0"
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
|
This prospective cross-over study aims to compare BIS values in supine and Trendelenburg positions. After achieving adequate anesthetic depth for surgery, BIS values will be recorded in the supine position at 0, 1, 2, 3, 4, and 5 minutes, followed by similar recordings in the Trendelenburg position. The primary objective is to evaluate changes in BIS between the two positions and assess the effect of Trendelenburg position on BIS before surgical stimulus, while the secondary objective is to study the effect of Trendelenburg position on systolic blood pressure ,diastolic blood pressure, mean arterial pressure , and heart rate .
|