| CTRI Number |
CTRI/2025/09/095028 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Different Anaesthesia Approaches for Pain Relief During Gallbladder Surgery |
|
Scientific Title of Study
|
Comparative Evaluation of Intraoperative Anti-Nociception Efficacy With Opioid Anaesthesia (Fentanyl) vs Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, Lignocaine) in Patients Undergoing Laparoscopic Cholecystectomy |
| 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 Arushi Saxena |
| Designation |
Post Graduate Resident |
| Affiliation |
School of Medical Sciences and Research, Sharda University |
| Address |
Department of Anaesthesiology, School of Medical Sciences and Research, Sharda Hospital, Sharda University, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8630764005 |
| Fax |
|
| Email |
arushisaxena05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U C Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
School of Medical Sciences and Research, Sharda University |
| Address |
Department of Anaesthesiology, School of Medical Sciences and Research, Sharda Hospital, Sharda University, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr U C Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
School of Medical Sciences and Research, Sharda University |
| Address |
Department of Anaesthesiology, School of Medical Sciences and Research, Sharda Hospital, Sharda University, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sharda Hospital, SMS and R, Sharda University, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India 201306 |
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology, School of Medical Sciences and Research, Sharda Hospital, Sharda University, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India 201310 |
| Type of Sponsor |
Private 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 Arushi Saxena |
Sharda Hospital, Sharda University |
Department of Anaesthesiology, School of Medical Sciences and Research, Sharda Hospital, Sharda University, Knowledge Park-3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India 201310
Gautam Buddha Nagar
UTTAR PRADESH |
8630764005
arushisaxena05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SCHOOL OF MEDICAL SCIENCES AND RESEARCH, SHARDA UNIVERSITY, GREATER NOIDA |
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 |
Fentanyl |
patients will receive an intravenous bolus injection of fentanyl 2 microgram per kg followed by infusion at 1 microgram per kg per hour will be started after 10 mins. repeat dose of fentanyl 10 microgram intravenous will be given if SPI exceeds 50.
Duration- 1 year 6 months |
| Intervention |
ketamine and lignocaine and dexmedetomidine |
Patients of group kld will receive an intravenous Injection Ketamine 0.3mg per kg and Injection Lidocaine 1.5mg per kg and Injection Dexmedetomidine 0.5mcg per kg. Continuous infusion of Lignocaine at the rate of 1.5mg per kg per hour and Dexmedetomidine at the rate of 0.2mcg per kg per hour will be continued till the skin closure. A repeat dose of Inj. Ketamine 0.2mg per kg IV bolus will be administered if the SPI exceeds 50.
Duration- 1 year 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient scheduled for laparoscopic cholecystectomy
Age between 18 to 60 years
ASA grade I and II
Both genders
Duration of surgery less than and equal to two hours |
|
| ExclusionCriteria |
| Details |
BMI more than 30 kg per meter square
Patient having history of drug allergy to Ketamine and
Lignocaine or Dexmedetomidine
History of usage of opioids and any other analgesics
Pregnant females
History of psychiatric illness
History of endocrine disease-diabetes mellitus and
thyroid disease, History of CNS, Cardiovascular or renal disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the intraoperative anti nociception efficacy with
opioid versus opioid free anaesthesia (Ketamine, lidocaine and Dexmedetomidine) by change in SPI in response to surgical noxious stimulation following skin incision till 24 hours. |
Perioperative till 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate & compare the intraoperative anti nociception efficacy with opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Dexmedetomidine) with regard
to:-
a) SPI (before & after intubation, before skin incision, before & after skin closure, before & after
extubation)
b) HR, MAP, Lacrimation, sweating (before & after intubation, skin incision, skin closure & extubation)
2) To evaluate & compare opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Dexmedetomidine) with regard to:-
a) Duration of Postoperative analgesia & pain severity
b) Incidence of Postoperative Nausea & Vomiting
c) Duration of discharge from Post Anaesthetic Care Unit
d) Post operative assessment of awarness
e) Total consumption of propofol, fentanyl, cis-atracurium, ketamine, lidocaine & dexmedetomidine |
Perioperative till 24 hours (postoperatively) |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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 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
|
This randomized, single-blinded clinical study aims to compare the intraoperative anti-nociception efficacy of opioid-based anaesthesia using fentanyl versus opioid-free anaesthesia using ketamine, lidocaine, and dexmedetomidine in patients undergoing laparoscopic cholecystectomy. The study design is Randomized, comparative, single blinded study and a total of 54 patients (27 in each group) will be enrolled and divided into two groups randomly. The primary outcome will be assessed using Surgical Pleth Index (SPI) values in response to surgical pain stimulation following skin incision. Secondary outcomes include heart rate, mean arterial pressure, lacrimation, sweating, postoperative pain scoring, analgesic requirements, postoperative nausea and vomiting, time to PACU discharge, intraoperative drug consumption, and awareness assessment. The goal is to evaluate whether opioid-free anaesthesia provides comparable analgesic efficacy while minimizing opioid-related side effects. |