| CTRI Number |
CTRI/2025/09/094353 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare efficacy of intravenous infusion of lidocaine with ketamine vs dexmedetomedine as opioid free anesthesia (OFA) |
|
Scientific Title of Study
|
Perioperative Analgesic Efficacy of Intravenous Infusion of Lidocaine with Ketamine Vs Dexmedetomedine as Opioid Free Anaesthesia (OFA): A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tania bansal |
| Designation |
Assistant professor |
| Affiliation |
Adesh institute of medical sciences and research bhucho mandi bathinda |
| Address |
Department of Anaesthesiology and Intensive Care,
Adesh institute of medical sciences and research bhucho mandi bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
7888768873 |
| Fax |
|
| Email |
tania24073@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tania bansal |
| Designation |
Assistant professor |
| Affiliation |
Adesh institute of medical sciences and research bhucho mandi bathinda |
| Address |
Department of Anaesthesiology and Intensive Care
Adesh institute of medical sciences and research bhucho mandi bathinda
PUNJAB
151001
India |
| Phone |
7888768873 |
| Fax |
|
| Email |
tania24073@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tania bansal |
| Designation |
Assistant professor |
| Affiliation |
Adesh institute of medical sciences and research bhucho mandi bathinda |
| Address |
Department of Anaesthesiology and Intensive Care
Adesh institute of medical sciences and research bhucho mandi bathinda
PUNJAB
151001
India |
| Phone |
7888768873 |
| Fax |
|
| Email |
tania24073@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh Institute Of Medical Sciences And Research Bhucho Mandi Bathinda 151001 Punjab India |
|
|
Primary Sponsor
|
| Name |
Tania bansal |
| Address |
Department of Anaesthesiology and Intensive Care
Adesh institute of medical sciences and research bhucho mandi bathinda |
| 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 Tania bansal |
Adesh institute of medical sciences and research bhucho mandi bathinda |
Department of anaesthesiology and intensive care
Adesh institute of medical sciences and research bhucho mandi bathinda punjab 151001
Bathinda
PUNJAB |
7888768873
tania24073@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee adesh university bathinda |
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 |
Opioid free anaesthesia |
Perioperative analgesic efficacy of opioid free anaesthesia using only intravenous infusion of lidocaine at a dose 1.5mg/kg/hr with intravenous infusion of 0.25mg/kg/hr ketamine vs intravenous infusion of 0.2mcg/kg/hr dexmedetomedine |
| Intervention |
Perioperative analgesic efficacy of opioid free anaesthesia using only intravenous infusion of lidocaine with ketamine vs dexmedetomedine |
Comparing perioperative analgesic efficacy of opioid free anaesthesia using only intravenous infusion of lidocaine at a dose 1.5mg/kg/hr with intravenous infusion of 0.25mg/kg/hr ketamine vs intravenous infusion of 0.2mcg/kg/hr dexmedetomedine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Short to intermediate duration surgeries requiring general anaesthesia |
|
| ExclusionCriteria |
| Details |
Non consenting patients
Patients less than 18yrs and more than 65yrs
Patients allergic to local anaesthetics
Prolonged duration of surgeries more than 2.5 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of infusion of preservative free lidocaine given systemically on analgesic efficacy of infusions of ketamine vs dexmedetomidine |
T0- At incision baseline
T1- 15 minutes
T2- 30 minutes
T3- 45 minutes
T4- 60 minutes
T5- 90 minutes
T6- 120 minutes
T7- 150 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study haemodynamic changes, side effects and complications of infusions of lidocaine added to infusions of ketamine and dexmedetomedine |
From incision during surgery under anaesthesia till post operative 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
05/10/2025 |
| 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="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
|
Opioids have been key components of general anesthesia practice from several decades, attributing to their analgesic, hypnotic effects and ability to provide hemodynamic stability intraoperatively. However opioids are associated with several well recognised side effects such as nausea, vomiting, sedation, ileus, urinary retention, pruritus, confusion, delirium, respiratory depression, increased morphine consumption, immunosuppression, hyperalgesia, chronic postoperative pain, addiction and misuse/abuse. This opioid crisis has questioned our general practice of perioperative use of opioids. Techniques are being developed to avoid these adverse effects. Opioid free anesthesia/ analgesia (OFA) or as is also called, opioid sparing technique (OSS), is an effort or ideology or technique where no intraoperative systemic, neuraxial or intracavitary opioid is administered with anesthesia. It is based on the concept of providing multimodal anesthesia/analgesia (MMA) techniques in order to avoid use of perioperative opioids. With this background in our mind, we decided to test this strategy using intravenous infusions of lidocaine in physiological doses to avoid systemic toxicity with either of the two, potent and well accepted agents viz; ketamine versus dexmedetomidine. |