CTRI Number |
CTRI/2018/01/011562 [Registered on: 25/01/2018] Trial Registered Retrospectively |
Last Modified On: |
23/01/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A Comparative study to decrease incidence of pain on injection of propofol using newer preparations of propofol emulsion. |
Scientific Title of Study
|
A comparative randomized double blind study comparing effect of 0.5% dilution of propofol
( MCT/LCT) with 0.5 % dilution of propofol (LCT) on Injection Pain During Induction of anaesthesia in paediatric patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR SAMEERA P |
Designation |
POST GRADUATE MD |
Affiliation |
VIMS |
Address |
Department of Anaesthesiology VIMS Ballari Karnataka
Bellary KARNATAKA 563122 India |
Phone |
9742326961 |
Fax |
9742326961 |
Email |
sameerapatel7464@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR BALA SUBRAMANYA H |
Designation |
PROFFESSOR, Department of anaesthesiology VIMS Ballari |
Affiliation |
VIMS |
Address |
Department of Anaesthesiology VIMS Ballari Karnataka
Bellary KARNATAKA 583104 India |
Phone |
9980600724 |
Fax |
|
Email |
halsanadu@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DRSAMEERA P |
Designation |
POST GRADUATE MD |
Affiliation |
VIMS |
Address |
Department of Anaesthesiology VIMS, Ballari Karnataka
#33, LVG block girls hostel VIMS Ballari
Bellary KARNATAKA 583104 India |
Phone |
9742326961 |
Fax |
|
Email |
sameerapatel7464@gmail.com |
|
Source of Monetary or Material Support
|
Department of anaesthesiology,Vijayanagar Institute of Medical Sciences, Ballari, Karnataka 583104 |
|
Primary Sponsor
|
Name |
Vijayanagar Institute of Medical Sciences Ballari |
Address |
Cantonment, Ballari |
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 |
DrSameera |
vijayanagar institute of medical sciences, Ballari |
Department of Anaesthesiology, VIMS Ballari Bellary KARNATAKA |
9742326961 9742326961 sameerapatel7464@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethical committee VIMS Ballari |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
children aged 6-12years under ASA 1 and 2 undergoing any elective surgical procedure under general anaesthesia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Pain on injection of propofol LCT |
Pain on injection of 0.5% propofol LCT in children aged 6-12 years under GA 0.5% Propofol LCT at a dose of 2mg/kg is used,after diluting 1% propofol LCT with 5% dextrose. |
Intervention |
Pain on injection of propofol MCT/LCT |
Pain on injection of 0.5% dilution of propofol MCT/LCT in children aged 6-12 years under GA. 0.5% Propofol MCT /LCT at a dose of 2mg/kg is used,after diluting 1% propofol MCT /LCT with 5% dextrose. |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
ASA 1 and ASA 2 patients |
|
ExclusionCriteria |
Details |
ASA 3 and 4 patients
co existing systemic disease
contra indication to propofol |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the effect of 0.5% dilution of propofol MCT/LCT with propofol LCT for injection pain during induction of general anaesthesia (GA) in paediatric patients. |
15 seconds, 30 seconds and 1 minute intervals. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the effect of 0.5 % dilution of propofol MCT/LCT with propofol LCT on haemodynamic changes during induction of GA in both the groups. |
15 seconds, 30 seconds and further at 1 minute intervals upto 5 minutes after induction |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/01/2016 |
Date of Study Completion (India) |
16/11/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None as of now |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Propofol is the most frequently used IV anaesthetic today. Propofol, when used for induction of anaesthesia in brief procedures, results in a significantly quicker recovery and an earlier return of psychomotor function compared with other induction agents. Induction ofanaesthesia is associated with several side effects with pain during intravenous injection being major among them. In view of the above consideration, this clinical study was performed to assess the comparative effects of 0.5% dilution of propofol MCT/LCT with 0.5% dilution of propofol LCT on injection pain. A hundred ASA physical status I & II patients ,aged 6-12 years, both male and female posted for various elective surgeries under general anaesthesia were studied. The patients were divided into two groups of fifty each: Group LCT &Group MCT/ LCT (N = 50 ), according to the computer generated list. Group LCT received 0.5% dilution of propofol (LCT) at 2mg/kg Group MCT/ LCT received 0.5% dilution of propofol (MCT LCT) at 2mg/kg Pain on propofol injection was assessed using Mc Crirrick and Hunter scale of evaluation of propofol injection pain.The patients in both groups were comparable with respect to demographic and hemodynamic parameters.Our study showed that 66% of group MCT/LCT and 12% of group LCT had no pain at all. While 8% in group MCT/LCT and 4% in group LCT had mild pain. The patients who experienced moderate pain were 18% in group MCT/LCT and 54% in group LCT,while only 8% had severe pain in group MCT/LCT compared to 30% in group LCT The difference in pain on injection was significantly less in group 0.5% MCT/LCT compared to group 0.5% LCT with P value of 0.0000 being highly significant. Hence we can conclude that using 0.5% dilution of propofol MCT/LCT has significantly reduced the incidence,intensity and severity of pain on propofol injection. |