| CTRI Number |
CTRI/2020/06/025742 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study if a smaller dose of propofol given prior to the actual dose will be able to reduce its total dose required. |
|
Scientific Title of Study
|
To study the effect of Priming principle on the induction dose requirement of propofol |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
reehana jabarulla |
| Designation |
post graduate |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCES AND SEARCH |
| Address |
Room no 629
new ladies hostel
Deparment of Anesthesiology,
PSG Institute of Medical Sciences and Research,
Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641 004
India |
| Phone |
8610578738 |
| Fax |
|
| Email |
jr2205@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R KAVITHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PSGIMSR |
| Address |
Deparment of Anesthesiology,
PSG Institute of Medical Sciences and Research,
Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641 004
India |
| Phone |
9840950928 |
| Fax |
|
| Email |
jojopritam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R KAVITHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PSGIMSR |
| Address |
PSGIMSR
PEELAMEDU
COIMBATIRE
641 004
PSGIMSR
PEELAMEDU
COIMBATORE
641 004
TAMIL NADU
641 004
India |
| Phone |
8610578738 |
| Fax |
|
| Email |
jojopritam@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF FUNDED
Dr reehana jabarulla
PSG institute of medical Sciences and Research
Peelamedu, Coimbatore,
PIN 641 004 |
|
|
Primary Sponsor
|
| Name |
REEHANA JABARULLA |
| Address |
Deparment of Anesthesiology,
PSG Institute of Medical Sciences and Research,
Peelamedu, Coimbatore
|
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 |
| REEHANA JABARULLA |
PSGIMSR |
OR complex,
Department of Anesthesiology,
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,
PEELAMEDU,
COIMBATORE
Coimbatore
TAMIL NADU |
8610578738
jr2205@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PSIMSR INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (2) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, (3) ICD-10 Condition: K35-K38||Diseases of appendix, (4) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (5) ICD-10 Condition: K40-K46||Hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PRIMING DOSE OF PROPOFOL PLUS DOSE REQUIRED TILL LOSS OF VERBAL RESPONSE |
FIRST THE PRIMING DOSE OF PROPOFOL WILL BE GIVEN i,e; 30% OF THE CALCULATED DOSE IS TAKEN AS THE PRIMING DOSE IN OUR STUDY.
THEN THE REMAINING DOSE WILL BE GIVEN AFTER TWO MINUTES BASED ON THE LOSS OF VERBAL RESPONSE OF THE PATIENT.
total calculated dose of drug - 2mg/kg
priming dose - 30% of the calculated dose
route of administration - Iv
|
| Comparator Agent |
TOTAL CALCULATED DOSE OF PROPOFOL
|
THE COMPARATOR AGENT IS PROPOFOL WHICH IS GIVEN AS THE TOTAL CALCULATED DOSE
dose - 2 mg/kg
duration of action - 9 minutes
route of administration - Iv
the drug will be given only once during induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
H/O allergy to egg, opioids
Alcoholics
H/O intake of CNS depressants
ASA 3 and 4
Haemodynamic instability
BMI > 35
Anticipated difficult intubation
Pregnancy and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the Effect of Priming Principle on the Induction dose requirement of Propofol. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Compare the Hemodynamics between the group in which Priming Principle was applied and the group in which No priming was applied.
|
1 year |
|
|
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)
|
30/06/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
induction of anesthesia is a crucial event in general anesthesia. Propofol is one of the commonly used intravenous induction anesthetic today, on account of its smoother and rapid onset, rapid emergence with remarkable orientation of patients and minimal side effects. in addition, one of the major benefits is the prevention of post operative nausea and vomiting. but on the other hand, as an induction agent propofol can have hemodynamic effects which are significant. in this study , we are applying priming principle, a sub anesthetic dose administration of propofol, with the aim of reducing the induction dose requirement and hence better hemodynamic stability.. |