| CTRI Number |
CTRI/2018/04/013125 [Registered on: 09/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the incidence and intensity of injection pain of two different formulations of drug propofol in patients requirin general anaesthesia |
|
Scientific Title of Study
|
“Propofol injection pain: a prospective double-blind trial of a Medium Chain Triglyceride/Long Chain Triglyceride (MCT/LCT) propofol formulation versus Long Chain Triglyceride (LCT)propofol formulation †|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supreeth R Shetty |
| Designation |
Assistant Professor |
| Affiliation |
SDM college of Medical sciences and hospital |
| Address |
Department of Anaesthesiology
SDM College of Medical Sciences and Hospital
Sattur,Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9945619565 |
| Fax |
|
| Email |
supreethrshetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh MCB |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology,
Mandya Institute of medical sciences,
Bangalore-Mysore road,
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Supreeth R Shetty |
| Designation |
Assistant Professor |
| Affiliation |
SDM college of Medical sciences and hospital |
| Address |
Department of Anaesthesiology
SDM College of Medical Sciences and Hospital
Sattur,Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9945619565 |
| Fax |
|
| Email |
supreethrshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of Medical Sciences and hospital |
|
|
Primary Sponsor
|
| Name |
SDM College of Medical Sciences and Hospital |
| Address |
Department of Anaesthesiology
SDM College of Medical Sciences and Hospital
Sattur, Dharwad, 580009
Karnataka, India |
| 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 |
| Supreeth R Shetty |
SDM College of medical sciences and hospital |
OT Complex,
Deapartment of Anaesthesia,
First Floor,
SDM college of Medical Sciences and Hospital,
Manjushree nagar, Sattur,Dharwad
Dharwad
KARNATAKA |
9945619565
supreethrshetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM college of medical Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1 and ASA 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Propofol LCT |
3o mg (3 cc ) of propofol LCT injected intravenously over 20 sec |
| Intervention |
Propofol MCT/LCT
(medium chain triglyceride/long chain triglyceride) |
30 mg (3 cc) of propofol MCT/LCT injected intravenously over 20 sec |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.The subjects who are aged between 18 to 60 years belonging to ASA Physical status 1 and 2.
2. Those willing to participate.
|
|
| ExclusionCriteria |
| Details |
1.Patients with ischaemic heart diseases, neurological or psychiatric problems, renal or hepatic insufficiency, suspected or known airway difficulty.
2. Pregnant or lactating women.
3. Those who were taking any analgesics before surgery.
4. Those with known hypersensitivity to propofol or to any of the constituents of emulsion.
5. Those who refuse to give consent.
|
|
|
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 |
pain on propofol induction and pain recall postoperatively.
Verbal rating scale for injection pain and recall pain used. |
Following 3cc of propofol induction pain will be assessed after 30 secs. Full dose of propofol will be given after assessing pain.
Pain recall postoperatively
30 mins after the patient is shifted to post operative ward |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in Pulse rate, Non invasive Blood pressure and Saturation |
pre induction, induction, postoperatively |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/12/2012 |
| Date of Study Completion (India) |
26/06/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, prospective, double blind trial performed to assess the incidence and intensity of propofol injection pain between two formulations. Two hundred ASA physical status I & II patients, posted for various elective surgeries under general anaesthesia were studied.The patients were divided into two groups of hundred each.Group L received 3 cc of LCT propofol and Group M received 3ccof LCT/MCT propofol . Patients were observed and questioned after 30sec of injection and pain was scored on a 4 point scale. Pain recall was done on the same 4 point scale 30 mins postoperatively. Both the incidence and intensity of pain was greater in group L compared with group M (p=0.0002). The mean pain score was also higher in group L (2.71) when compared with group M (1.08). Propofol MCT/LCT reduces both intensity and incidence of pain on injection.
|