| CTRI Number |
CTRI/2025/05/087154 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| 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 compare how well low doses of ketamine or lignocaine work to prevent pain when propofol is injected into a vein. The study is done in a fair and unbiased way, where neither the patients nor the researchers know who gets which medicine |
|
Scientific Title of Study
|
A Randomised Double-Blind Controlled Study to Evaluate the Efficacy of Low-Dose Intravenous Ketamine Versus Intravenous Lignocaine for Prevention of Pain Associated With Intravenous Injection of Propofol |
| 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 Veena Patodi |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology, new OT,1st floor JLN medical hospital kalabagh,Ajmer Rajastan
Ajmer
RAJASTHAN
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology, new OT,1st floor JLN medical hospital kalabagh,Ajmer Rajastan
Ajmer
RAJASTHAN
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology, new OT,1st floor JLN medical hospital kalabagh,Ajmer Rajastan
Ajmer
RAJASTHAN
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology JLN medical college and hospitals, Kalabhag road, Ajmer Rajastan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college |
| Address |
kalabagh,Ajmer,Rajasthan,India
pin code- 305001 |
| Type of Sponsor |
Government 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 Mohit Gurjar |
JLN medical college and hospital |
Department of Anaesthesiology, new OT 1st floor, JLN hospital kalabagh
Ajmer
RAJASTHAN
Ajmer
RAJASTHAN |
7737800956
drmohitgurjar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee Jawaharlal nehru medical college and hospitals ajmer |
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 |
GROUP A - inj. Ketamine |
inj. ketamine 0.2 mg/kg iv |
| Comparator Agent |
GROUP B- Inj. Lidocaine |
Inj. Lidocaine 0.5mg/kg iv |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I, II
2. Elective surgical procedure under general anesthesia
3. Patients willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients having known allergy to propofol and anesthetic agents will be used in
study.
2. Hemodynamically unstable patient, Pregnant women, morbidly obese, history of
neurological & psychological disorders, with acute or chronic pain syndromes,
patients with difficulty in communication and patients who had received any
sedatives and analgesic medications before surgery
3.Patients who are unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Difference in number of cases who experience pain on injection in both groups.
|
To assess and compare prevention of pain associated with iv injection of propofol in both groups at different time intervals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Difference in hemodynamic variations from base line at different time interval in
both groups.
2. Difference in number of cases who has side effect in both groups. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/05/2025 |
| 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 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
|
Propofol (2,6-diisopropylphenol) is currently the most widely used intravenous anesthetic agent due to its favorable pharmacological profile, including smooth induction, effective sedation, rapid recovery, and anti-emetic properties compared to agents such as thiopental However, its use is frequently accompanied by a significant drawback: pain on injection, which is a common and distressing issue for patients. The pain associated with propofol injection is believed to be primarily due to the concentration of free propofol in the aqueous phase of the emulsion .As a phenol derivative, propofol can irritate the skin, mucous membranes, and venous intima. Injection pain may be immediate, due to direct irritation of afferent nerve endings, or delayed. Various strategies have been proposed to mitigate this pain, including altering the temperature or concentration of propofol, using larger veins for injection, and pre-treatment with intravenous agents such as lidocaine, ondansetron, metoclopramide, opioids, magnesium, or thiopental, with or without a tourniquet. Among these, lidocaine pre-treatment remains the most commonly used method to reduce propofol injection pain.However, lidocaine does not entirely eliminate the discomfort. Ketamine, known for its potent analgesic and local anesthetic effects, has also been explored as a potential alternative.As an NMDA receptor antagonist, ketamine may reduce pain through peripheral mechanisms and central modulation of pain pathways Furthermore, ketamine’s sympathetic stimulatory effects can help stabilize hemodynamics following propofol administration, a potential added benefit over lidocaine Variability in pain perception. This study compares lignocaine and ketamine in prevention of pain associated with iv injection of propofol. |