| CTRI Number |
CTRI/2025/08/092288 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparative evaluation of intraoperative anti- nociception efficacy with opioid(fentanyl) versus opioid free anesthesia(ketamine and lidocaine and magnesium sulphate) in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
comparative evaluation of intraoperative anti- nociception efficacy with opioid(fentanyl) versus opioid free anesthesia(ketamine and lidocaine and magnesium sulphate) 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 |
jayantika madhwani |
| Designation |
post graduate resident |
| Affiliation |
school of medical sciences and research sharda university |
| Address |
Department of anesthesiology School of medical sciences and research Sharda hospital Sharda university
knowledge park 3 greater noida gautam buddh nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8766239031 |
| Fax |
|
| Email |
jayantikamadhwani17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr UC Verma |
| Designation |
professor |
| Affiliation |
school of medical sciences and research sharda university |
| Address |
Department of anesthesiology School of medical sciences and research Sharda hospital Sharda university
knowledge park 3 greater Noida Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr UC Verma |
| Designation |
professor |
| Affiliation |
chool of medical sciences and research sharda university |
| Address |
Department of anesthesiology School of medical sciences and research Sharda hospital Sharda university
knowledge park 3 greater Noida Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research Sharda university |
| Address |
Knowledge park 3, Greater Noida Gautam Buddh Nagar, Uttar Pradesh |
| 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 UC Verma |
Department of Anaesthesiology |
School of Medical Sciences and Research Sharda Hospital Sharda University knowledge park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9968604211
uttam.verma@sharda.ac.in |
|
|
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 |
| Intervention |
fentanyl |
patients will receive an intravenous bolus injection of fentanyl 2 microgram per kg f/b infusion at 1 microgram per kg per hour. repeat dose of fentanyl 10 microgram intravenous will be given if SPI exceeds 50
Duration- 1 year 6 months |
| Comparator Agent |
ketamine or lignocaine or magnesium sulphate |
Patients will receive an intravenous bolus of Injection Ketamine 0.3mg per kg or Injection
Lidocaine 1.5mg per kg and Injection Magnesium sulphate 50mg per kg. Infusion of Lignocaine at the rate
of 1.5mg per kg per hour and Magnesium sulphate at the rate of 20mg 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 lidocaine and Magnesium Sulphate.
History of chronic usage of opioids and any other analgesics.
Pregnant females
History of psychiatric illness.
History of endocrine disease example diabetes mellitus and thyroid disease.
History of CNS or Cardiovascular and 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 Magnesium sulphate) by change
in SPI in response to surgical noxious stimulation following skin incision till 24 hours. |
To evaluate and compare the intraoperative anti nociception efficacy with
opioid versus opioid free anaesthesia (Ketamine, lidocaine and Magnesium sulphate) by change in SPI in response to surgical noxious stimulation following skin incision 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 & Magnesium sulphate) 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) |
peri operative monitoring till 24 hours post operatively |
To evaluate & compare opioid (fentanyl) versus opioid free anaesthesia (Ketamine,
lidocaine & Magnesium sulphate) 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 &
magnesium sulphate. |
peri operative till post operative 24 hours. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2030 |
| 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)
|
Closed to Recruitment of Participants |
| 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 magnesium sulphate in adult patients undergoing laparoscopic cholecystectomy. A total of 54 patients will be enrolled and divided into two groups. The primary outcome will be assessed using Surgical Pleth Index (SPI) values in response to skin incision. Secondary outcomes include heart rate, mean arterial pressure, lacrimation, sweating, postoperative pain scores, 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. |