| CTRI Number |
CTRI/2025/08/092480 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Correlation of different anesthetic agents with pupillary diameter |
|
Scientific Title of Study
|
Comparative evaluation of pupillometry changes during sevoflurane versus propofol anesthesia in patients undergoing laparoscopic cholecystectomy under general anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Natasha Yadav |
| Designation |
Postgraduate resident |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
3rd floor, BL Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7291842699 |
| Fax |
|
| Email |
natashayadav04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Bharti Wadhwa |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
3rd floor, BL Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
09968604221 |
| Fax |
|
| Email |
drbhartitaneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Bharti Wadhwa |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
3rd floor, BL Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
09968604221 |
| Fax |
|
| Email |
drbhartitaneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadurshah Zafar Marg, New Delhi 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 Natasha Yadav |
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
Central
DELHI |
7291842699
natashayadav04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol group |
In the propofol group, anaesthesia will be maintained by administration of propofol using Schneider pharmacokinetic model of Target-Controlled Infusion (TCI) pump. Initial effect site concentration (Ce) will be set at 2µg/ml titrated to maintain qCON between 40-60 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having American Society of Anesthesiologists (ASA) physical status I and II.
2. BMI less than or equal to 30 kg/m² |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating patients
2. History of allergy to any study drug
3. Patients on antipsychotics medications
4. Neurological disorders and ophthalmic disordersaffecting pupillary size or reaction
5. History of head trauma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pupillary diameter (PD) in patients undergoing propofol and sevoflurane anesthesia at the time of incision at comparable depths of sedation and nociception. |
TO (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 |
Pupillary diameter at other predefined time intervals
|
TO (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 |
| Change in pupillary diameters from baseline diameters at various predefined time intervals during the procedure |
TO (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="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)
|
20/08/2025 |
| 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="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 comparing changes in pupillary diameter with propofol and sevoflurane anesthesia in patients posted for laparoscopic cholecystectomy in Lok Nayak Hospital, Delhi. A total of 70 patients will be enrolled in the study—35 patients in each group. Patients will be explained about the study, and written informed consent will be taken. CONOX monitor electrodes will be attached to patients’ foreheads to record qNOX and qCON values, and a pupillometer will be used to record pupillary diameters. We will be using standard general anesthesia for induction of the patients, and pupillary diameter and qNOX and qCON values will be recorded at certain time intervals during the surgery. Intraoperative analgesic administration will be guided by qNOX. |