| CTRI Number |
CTRI/2025/08/092615 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study - Analytical |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess how body signals measured during surgery can predict pain levels after gall bladder surgery. |
|
Scientific Title of Study
|
Correlation of Surgical Pleth Index measured at different time intervals with postoperative pain 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 |
Reshma P |
| Designation |
PG Resident |
| Affiliation |
ABVIMS and DR. RML Hospital |
| Address |
Department of Anaesthesia,
ABVIMS and DR.RML Hospital, Baba Kharak Singh Road, Connaught Place, New Delhi.
New Delhi
DELHI
110001
India |
| Phone |
6384553681 |
| Fax |
|
| Email |
reshmapichandi23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEERJA BANERJEE |
| Designation |
Professor |
| Affiliation |
ABVIMS and DR. RML Hospital |
| Address |
Department of Anaesthesia,
ABVIMS and DR.RML Hospital, Baba Kharak Singh Road, Connaught Place, New Delhi.
New Delhi
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEERJA BANERJEE |
| Designation |
Professor |
| Affiliation |
ABVIMS and DR. RML Hospital |
| Address |
Department of Anaesthesia,
ABVIMS and DR.RML Hospital, Baba Kharak Singh Road, Connaught Place, New Delhi.
New Delhi
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, ABVIMS and DR. RML Hospital, Baba Kharak Singh Road, 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, 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 |
| Dr Neerja Banerjee |
ABVIMS and Dr. RML Hospital |
Department of Anaesthesia, 3rd floor PGIMER Building.
New Delhi
DELHI |
9810517575
neerja.banerjee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ISTITUTIONAL 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients on chronic pain medications, History of psychiatric illness or cognitive dysfunction, Conversion to open Cholecystectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surgical pleth index measured at 4 time intervals and Post operative pain assessment done in PACU by using NRS. |
SPI measured at different time intervals 5 minutes before induction, 5 minutes after Veress needle insertion, 5 minutes after Laparoscopic port insertion and 10 minutes before extubation and Post operative pain assessment done in PACU by using NRS at 5, 10, and 15 minutes after recovery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Surgical Pleth index and hemodynamic parameters such as Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) measured at 4 time intervals. |
5 minutes before induction, 5 minutes after Veress needle insertion, 5 minutes after Laparoscopic port insertion and 10 minutes before extubation. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
21/08/2025 |
| 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 correlate the surgical pleth index measured at different time intervals with postoperative in patients undergoing laparoscopic cholecystectomy under general anaesthesia, to be conducted in ABVIMS and DR RML Hospital, New Delhi, 110001. Sample Size=70
The Primary objective is to study the correlation of surgical pleth index measured at 4 time intervals with Postoperative pain in patients undergoing laparoscopic cholecystectomy under General Anaesthesia.
The Secondary objective is to study the correlation between Surgical pleth index and hemodynamic parameters measured at different time intervals with postoperative pain in patients undergoing laparoscopic cholecystectomy under General Ananesthesia. |