| CTRI Number |
CTRI/2026/02/104523 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate changes in perfusion index in response to painful stimuli in patients undergoing gall bladder removal surgery under general anaesthesia |
|
Scientific Title of Study
|
A study to evaluate Perfusion index(PI)
as a tool to assess analgesia during 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 |
Shubhada Bhagat |
| Designation |
Associate Professor |
| Affiliation |
Pt. B.D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesia,PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9540927325 |
| Fax |
|
| Email |
shubhadabhagat56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritu |
| Designation |
Post Graduate student |
| Affiliation |
Pt. B.D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesia,PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8684881338 |
| Fax |
|
| Email |
Khatriritu2296@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhada Bhagat |
| Designation |
Associate Professor |
| Affiliation |
Pt. B.D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesia,PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9540927325 |
| Fax |
|
| Email |
shubhadabhagat56@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shubhada Bhagat |
| Address |
Department of anaesthesiology and critical care,Pt. B.D Sharma PGIMS Rohtak |
| 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 Shubhada Bhagat |
Pt. B.D Sharma,PGIMS,Rohtak |
Department of anaesthesia,PGIMS,Rohtak
Rohtak
HARYANA |
9540927325
shubhadabhagat56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, PGIMS ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Standard anaesthesia protocol along with 0.5 µg/kg of intravenous fentanyl will be given after 2nd port insertion in patients undergoing laparoscopic cholecystectomy. |
Standard anaesthesia protocol will be given. In addition,0.5 µg/kg intravenous fentanyl will be given after 2nd port insertion. Changes in PI after painful stimuli at various time points will be noted. In addition to the above, changes in PI after additional analgesic administration after 2nd port insertion will be noted. |
| Comparator Agent |
Standard anaesthesia protocol without additional fentanyl will be administered to patients undergoing laparoscopic cholecystectomy. |
Standard anaesthesia protocol will be given. No additional fentanyl will be given after 2nd port insertion. Changes in PI after painful stimuli at various time points will be noted. Changes in PI without additional fentanyl after 2nd port insertion will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I&II |
|
| ExclusionCriteria |
| Details |
Chronic pain disorder
Neurological diseases, Peripheral vascular diseases, Hypertension ,Diabetes mellitus,Cardiovascular diseases, Psychiatric diseases, Refusal to consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether a statistically significant variation occur in perfusion index in response to painful stimuli and in response to analgesic administration in laparoscopic cholecystectomy under general anaesthesia. |
P0: BaselineP1: Pre-inductionP2: Before intubationP3: After intubationP4: First port insertionP5: PneumoperitoneumP6: Second port insertion (fentanyl given in Group F)P7: Third port insertionP8: Fourth port insertionP9: 5 min after fourth portP10: 10 min after fourth portP11: 15 min after fourth portP12: 30 min after fourth port |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine if statistically significant changes in perfusion index occur with changes in HR and MAP |
P0: BaselineP1: Pre-inductionP2: Before intubationP3: After intubationP4: First port insertionP5: PneumoperitoneumP6: Second port insertion (fentanyl given in Group F)P7: Third port insertionP8: Fourth port insertionP9: 5 min after fourth portP10: 10 min after fourth portP11: 15 min after fourth portP12: 30 min after fourth port. |
|
|
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)
|
06/03/2026 |
| 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 prospective randomized controlled trial aims to evaluate changes in perfusion index (PI) as a tool to assess analgesia during laparoscopic cholecystectomy under GA. 40 patients belonging to ASA I and ASA II will be included in the study. Patients will be randomly allocated into 2 groups of 20 patients each. Group F will receive 0.5 mcg/kg of fentanyl after 2nd port insertion. Group C (n=20) will receive anaesthesia as per standard protocol. Primary outcome of the study is to determine whether a statistically significant variation occurs in perfusion index in response to painful stimuli and in response to analgesic administration in laparoscopic cholecystectomy under general anaesthesia. Secondary outcome of this study is to determine if statistically significant changes in PI occurs with changes in HR and MAP. |