| CTRI Number |
CTRI/2025/07/090419 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how patient position affects the level of consciousness during keyhole gallbladder surgery under general anaesthesia. |
|
Scientific Title of Study
|
Effect of patient positions on the Bispectral Index and Entropy Index in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ria Treasa James |
| Designation |
Postgraduate Resident |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesia, ABVIMS and Dr. RML Hospital, Baba
Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
8777470589 |
| Fax |
|
| Email |
riatreasajames@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupesh Yadav |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesia, ABVIMS and Dr. RML Hospital, Baba
Kharak Singh Road, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9460720444 |
| Fax |
|
| Email |
drrupesh.yadav98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupesh Yadav |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesia, ABVIMS and Dr. RML Hospital, Baba
Kharak Singh Road, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9460720444 |
| Fax |
|
| Email |
drrupesh.yadav98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, ABVIMS and Dr. RML Hospital, Baba Kharak Singh Road, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi - 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesia, ABVIMS and Dr. RML Hospital, Baba Kharak Singh Road, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi - 110001 |
| Type of Sponsor |
Government 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 |
| Rupesh Yadav |
ABVIMS and Dr. RML Hospital |
Department of anaesthesia, ABVIMS and Dr. RML Hospital, Baba Kharak Singh Road, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi - 110001
New Delhi
DELHI |
9460720444
drrupesh.yadav98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS and Dr. RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists physical status I and II patients posted for elective Laparoscopic Cholecystectomy under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients with history of previous neurosurgery
2. Patients with known neurological or cognitive disorders
3. Patients taking psychiatric medications
4. Patients taking drugs that act on the central nervous system |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bispectral Index and Entropy Index values in different patient positions
(1. Supine/Neutral
2. Head up(30 degrees with left lateral tilt(15 degrees)
3. Supine/Neutral) |
1. Baseline
2. 15 secs
3. 30 secs
4. 1 min
5. 2 mins
6. 5 mins
7. 10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic Parameters( Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure and Heart Rate)in different patient positions |
1. Baseline
2. 15 secs
3. 30 secs
4. 1 min
5. 2 mins
6. 5 mins
7. 10 mins |
| Time taken for values of Bispectral Index and Entropy Index to return to Target Value |
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2025 |
| 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="1"
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
|
This is an observational study to assess the impact of different patient positions on Bispectral Index and Entropy Index in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia which will be conducted at ABVIMS and Dr. RML Hospital, New Delhi - 110001. The sample size for the study is 100.
The primary objective is to study the change in the values of Bispectral Index and Entropy Index in different patient positions in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia.
The study has two secondary objectives. The first is to study the changes in hemodynamic parameters( Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and Mean Arterial Pressure) with change in position in the study population.The second is to measure the time taken for values of Bispectral Index and Entropy Index to return to target value.
In each subject, baseline values of Bispectral Index, Entropy Index and hemodynamic parameters will be recorded in neutral supine position. The subject’s position will the be changed to head up(30 degrees) with left lateral tilt(15 degrees) and the values of Bispectral Index, Entropy Index and hemodynamic parameters will be recorded at baseline, 15 secs, 30 secs, 1min, 2mins, 5 mins and 10 mins. The time taken for the values of Bispectral Index and Entropy Index to return to target value will also be noted. The subject’s position will the be changed to neutral supine and the values of Bispectral Index, Entropy Index and hemodynamic parameters will be recorded at baseline, 15 secs, 30 secs, 1min, 2mins, 5 mins and 10 mins. The time taken for the values of Bispectral Index and Entropy Index to return to target value will also be noted. |