| CTRI Number |
CTRI/2026/04/107527 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Precision Pain Management vs. Routine Care in Laparoscopic Gallbladder Surgery |
|
Scientific Title of Study
|
Efficacy Of Surgical Plethysmographic Index-guided Analgesia Versus Conventional Analgesia Technique In Laparoscopic Cholecystectomy Using Remifentanil |
| 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 Naresh Dua |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Room No 10, 5th Floor, Institute of Anaesthesiology, Pain & Perioperative Medicine, SGRH,Old Rajinder Nagar
New Delhi
DELHI
110060
India |
| Phone |
9313097996 |
| Fax |
|
| Email |
ndua17@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Dua |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Room No 10, 5th Floor, Institute of Anaesthesiology, Pain & Perioperative Medicine, SGRH,Old Rajinder Nagar
New Delhi
DELHI
110060
India |
| Phone |
9313097996 |
| Fax |
|
| Email |
ndua17@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishti |
| Designation |
DNB Trainee |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Room No 10, 5th Floor, Institute of Anaesthesiology, Pain & Perioperative Medicine, SGRH,Old Rajinder Nagar
New Delhi
DELHI
110060
India |
| Phone |
9334102689 |
| Fax |
|
| Email |
srishtidoc09@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
SGRH,Old Rajinder Nagar, New Delhi- 110060 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Naresh Dua |
Sir Ganga Ram Hospital |
OT 5, 6th floor SSRB building, SGRH, Old Rajinder Nagar
New Delhi
DELHI |
9313097996
ndua17@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
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 |
| Comparator Agent |
conventional remifentanil analgesia |
Intraoperative remifentanil infusion titrated according to standard clinical parameters including heart rate and mean arterial pressure under standardized general anesthesia protocol |
| Intervention |
Surgical plethysmographic index guided analgesia |
Intraoperative remifentanil infusion titrated according to Surgical plethysmographic index monitoring to maintain SPI within target range during laparoscopic cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females, aged 18-65 years
ASA physical classification I to II |
|
| ExclusionCriteria |
| Details |
Known uncontrolled cardiovascular disease (e.g., hypertension, systolic and diastolic dysfunction)
Liver function abnormality (liver enzymes more than 2 times the normal range)
Kidney function abnormality (serum creatinine more than 1.4 mg/dl)
Known psychiatric or neurological disorder
Known uncontrolled endocrine disorder (diabetes mellitus, hypothyroidism)
Known allergy or hypersensitivity to the study drug
Recent intake of sedative medication or anti-psychotic medication
Substance abuse
Anticipated need for postoperative ventilation
Refusal to informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative Remifentanil Consumption |
from induction of anaesthesia to competion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Postoperative pain (10-point NRS) during the first 24-hrs postoperative period
2. Postoperative nausea and vomiting (3-point PONV score) during the first 24-hrs postoperative period
3. Intraoperative haemodynamic instability (bradycardia/ tachycardia/ hypotension/ hypertension)
|
immediately after shifting to recovery, 6 hours and 24 hours after recovery |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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)
|
15/04/2026 |
| 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="2"
Months="0"
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
|
Study comparing surgical plethysmographic index guided analgesia with conventional analgesia technique using remifentanil in patients undergoing laparoscopic cholecystectomy. The aim of the study is to evaluate whether intraoperative analgesia guided by surgical plethysmographic index provides better hemodynamic stability and optimized opioid consumption compared to conventional analgesia technique. A total of 184 adult patients will be randomly allocated into two groups. One group will receive analgesia guided by surgical plethysmographic index and the other group will receive conventional analgesia based on standard clinical parameters. Intraoperative hemodynamic variables, total opioid consumption and postoperative pain scores will be assessed and compared between the two groups |