CTRI Number |
CTRI/2023/12/060528 [Registered on: 19/12/2023] Trial Registered Prospectively |
Last Modified On: |
18/12/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
A clinical trial to compare the effects of 3 drugs - Dexmeditomedine, Ketamine and Preservative free lignocaine in reducing the pain caused by injection of propofol |
Scientific Title of Study
|
"Comparison of intravenous pretreatment with dexmeditomedine, ketamine and preservative free lignocaine in alleviating propofol injection pain -- A prospective randomized study." |
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 Sanju Ashokkumar |
Designation |
Postgraduate student |
Affiliation |
Shimoga institute of medical sciences |
Address |
Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences
Shimoga KARNATAKA 577201 India |
Phone |
9663149347 |
Fax |
|
Email |
sanjuashokkumar@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shivanandha PT |
Designation |
Professor and HOD |
Affiliation |
Shimoga Institute of Medical Sciences |
Address |
Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences
Shimoga KARNATAKA 577201 India |
Phone |
9986327599 |
Fax |
|
Email |
shivananda1233@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shivanandha PT |
Designation |
Professor and HOD |
Affiliation |
Shimoga Institute of Medical Sciences |
Address |
Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences
Shimoga KARNATAKA 577201 India |
Phone |
9986327599 |
Fax |
|
Email |
shivananda1233@gmail.com |
|
Source of Monetary or Material Support
|
McGANN TEACHING DISTRICT HOSPITAL
Mission compund, Shivamogga
577201
Karnataka
|
|
Primary Sponsor
|
Name |
Dr Sanju Ashokkumar |
Address |
Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences |
Type of Sponsor |
Other [self] |
|
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 Sanju Ashokkumar |
McGANN TEACHING DISTRICT HOSPITAL |
Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences Shimoga KARNATAKA |
9663149347
sanjuashokkumar@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE(IEC)SIMS |
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 |
DEXMEDITOMEDINE |
Group D will receive dexmeditomedine (0.25mcg/kg) diluted with normal saline upto 5ml |
Comparator Agent |
KETAMINE |
Group K will receive Ketamine (0.2mg/kg) diluted with normal saline upto 5ml |
Comparator Agent |
PRESERVATIVE FREE LIGNOCAINE |
Group L will receive preservative free lignocaine (0.5mg/kg) diluted with normal saline upto 5ml |
Intervention |
PROPOFOL |
25% of the calculated dosage of propofol will be administered to the patient over a period of 60 seconds before induction of anaesthesia |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients who are willing to participate in the study
2. Patients undergoing surgeries that require general anaesthesia with propofol as
induction agent
3. Age group of 18-60 of either sex
4. American society of anaesthesiologist (ASA) physical status I and II |
|
ExclusionCriteria |
Details |
1.History of drug allergy
2.Patients who dont fit in the age/ ASA criteria
3.History of psychiatric disorder
4.History of seizure disorder
5.History of substance abuse |
|
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 |
To compare the efficacy of intravenous dexmeditomedine ,ketamine and preservative free lignocaine in reducing the Intensity of pain upon injection of propofol graded on a four point scale (0-3)
None (0) - No response to questioning
Mild (1) - Pain reporting in response to questioning only
Moderate (2) - Pain reporting in response to questioning and or pain reported spontaneously without questioning
Severe (3) - Strong vocal response accompanied by facial grimace, arm withdrawals or tears |
0 seconds, 30 seconds and 60 seconds |
|
Secondary Outcome
|
Outcome |
TimePoints |
The hemodynamic variability in patients upon injecting these study agents. |
0 seconds and 1 minute |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
01/01/2024 |
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 Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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 is one of the most commonly used induction agents in anaesthesia practice.Due to its sedative and hypnotic properties, its usage in TIVA and procedural sedation has become a common practice. Continous IV infusion of propofol is also used extensively for producing IV sedation, especially in ICU setups. Its favourable features include quick onset of action, rapidity in causing loss of consciousness, pleasant sleep and quick smooth recovery and no postoperative nausea and vomiting. It causes pain when given intravenously, the incidence varying from 28% to 98% in adults during induction of anaesthesia. The theories for this pain include activation of plasma kallikrein-kinin system, oil emulsion preparation, osmolality of the solvent used to make the preparation and the pH of the solution. Propofol injection pain can cause sympathetic activation, may induce unwanted apprehension and anxiety, leading to an unpleasant general anaesthesia experience. Several methods have been tried to attenuate this pain, such as increasing flow rate, injecting it into larger vein, adding various opioids, cooling/dilution of propofol and pre- treatment with other drugs like ondansetron, ephedrine, metaclopramide, nafamostate mesilate, thiopentone sodium etc. The most extensively used method is pretreatment with lignocaine. It reduces pain during propofol injection by its local anaesthetic action and also by stabilising kinin cascade. However, it has a failure rate of 13-32%. Ketamine, a phencyclidine derivative apart from being a good general anaesthetic agent, also has analgesic and local anaesthetic effects. This can be attributed to its antagonistic action on NMDA receptors, thereby can help in reducing propofol induced pain. Recently Alpha 2 adrenergic agonists like clonidine have also been known to alleviate propofol injection pain. A more selective alpha 2 adrenergic agonist like dexmeditomedine , which also has analgesic and sedative properties has been researched to combat this pain. There are limited studies comparing these drugs for reduction of propofol pain. In this study, we propose to compare intravenous dexmeditomedine , intravenous ketamine and intravenous preservative free lignocaine in reducing propofol injection pain. |