| CTRI Number |
CTRI/2024/05/067636 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pupil size and nociception index for pain evaluation in gall bladder surgery |
|
Scientific Title of Study
|
Correlation of Pupillary diameter with Quantium Nociception Index for estimation of intraoperative 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 |
Dr Himanshu Garg |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No. 304, 3rd floor, BL Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9991254510 |
| Fax |
|
| Email |
himanshu.garg1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Nath Saxena |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No. 304, 3rd floor, BL Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604215 |
| Fax |
|
| Email |
kirtinath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Garg |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No. 304, 3rd floor, BL Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9991254510 |
| Fax |
|
| Email |
himanshu.garg1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadurshah Zafar Marg, New Delhi
India
110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadurshah Zafar Marg, New Delhi 110002 |
| 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 Himanshu Garg |
Lok Nayak Hospital |
Department of Anaesthesiology and intensive care, BL Taneja block, Maulana Azad Medical College and associated Lok Nayak Hospital, JLN Marg, New Delhi
Central
DELHI |
9991254510
himanshu.garg1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 to 60 years of age of either sex
2. American Society of Anaesthesiologists Physical Status I and II
3. Body Mass Index less than/ equal to 30Kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactation
2.Psychiatric illness and patient suffering from intellectual disability
3.History of comorbidities such as Hypertension or any cardiac disease
4.History of allergy to any drug as per protocol
5.History of use of psychoactive drugs
6.Any neurological disorders
7.Eye disorders affecting pupillary size or reaction
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establish the correlation between pupillary diameter and quantium nociception index (qNOX) values for estimation of intraoperative pain during general anaesthesia in laparoscopic cholecystectomy |
T0(Baseline) – before induction
T1 - 1 min after induction
T2 - At skin incision
T3 - During trochar insertion
- every 15 min interval following T3
-At the end of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between pupillary diameter and hemodynamic parameters (HR, SBP, DBP, MAP) at different time intervals. |
T0(Baseline) – before induction
T1 - 1 min after induction
T2 - At skin incision
T3 - During trochar insertion
-every 15 min interval following T3
-At the end of surgery
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2024 |
| 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="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
|
We are correlating change in pupillary diameter with quantium nociception index (qNOX) for estimation of intraoperative pain in patients posted for laparoscopic cholecystectomy in Lok Nayak Hospital, Delhi. A total of 40 patients will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. CONOX monitor electrodes will be attached to patients’ forehead to record qNOX values and pupillometer will be used to record pupillary diameters. We will be using standard general anaesthesia for induction of the patients and pupillary diameter and qNOX values will be recorded at certain time intervals during the surgery. Intraoperative analgesic administration will be guided by qNOX. At the end, numerical rating scale will be used to assess pain postoperatively. |