| CTRI Number |
CTRI/2021/06/033990 [Registered on: 04/06/2021] Trial Registered Prospectively |
| Last Modified On: |
03/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different doses of propofol and its effect on hemodynamic response |
|
Scientific Title of Study
|
A comparative study of haemodynamic responses of propofol induction between BIS guided dose and sleep dose |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 183/6/PGT-2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sentila Shangne |
| Designation |
Post graduate trainee |
| Affiliation |
Jawaharlal Nehru Institute of Medical sciences |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Institute of Medical sciences, Porompat
Imphal East
Imphal East
MANIPUR
795005
India |
| Phone |
8974696820 |
| Fax |
|
| Email |
sentilas101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Keisham Upendra |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Nehru Institute of Medical sciences |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Institute of Medical sciences Porompat
Imphal East
Imphal East
MANIPUR
795005
India |
| Phone |
9436039203 |
| Fax |
|
| Email |
drupendrakeisham@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keisham Upendra |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Nehru Institute of Medical sciences |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Institute of Medical sciences Porompat
Imphal East
Imphal East
MANIPUR
795005
India |
| Phone |
9436039203 |
| Fax |
|
| Email |
drupendrakeisham@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional
Jawaharlal Nehru Institute of Medical sciences |
|
|
Primary Sponsor
|
| Name |
Sentila Shangne |
| Address |
Room no.F-12,3rd floor
Faculty quarter Block-B, JNIMS Porompat 795005 |
| 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 |
| Sentila Shangne |
Jawaharlal Nehru Institute of Medical sciences |
Department of Anaesthesiology,
POROMPAT -
795005
Imphal East
MANIPUR |
8974696820
sentilas101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,JNIMS |
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 |
Not Applicable |
Not Applicable |
| Intervention |
Propofol |
Comparison between sleep dose and BIS guided dose of propofol on haemodynamics.
Sleep dose of propofol given by bolus intravenously till patient has loss of verbal command and BIS guided dose by giving propofol intravenously till BIS value is between 40-60. Haemodynamics is measured in the first 5,10 and 15 minutes after induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2
Elective surgeries under general anaesthesia
Patients with a signed informed written consent form
|
|
| ExclusionCriteria |
| Details |
Patient refusal
History of cardiac diseases like dilated cardiomyopathy,CCF, Arrhythmias etc
History of uncontrolled hypertension and hypotension
Patients with hepatic or renal dysfunction, pregnancy or any serious medical conditions that would interfere with cardiovascular response
Patients with history of allergy to any GA drugs
Cases lasting less than 30mins
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare sleep guided dose of propofol with BIS guided dose on haemodynamic response |
Baseline,15minutes intraoperative and 15minutes postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess sedation scale |
Postoperative Period upto 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 4 |
|
Date of First Enrollment (India)
|
12/06/2021 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The study will be published in a peer reviewed journal once the study is completed. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomised controlled trial will be conducted in my institution to compare the haemodynamic responses of propofol using the sleep dose of Propofol and BIS guided dose of Propofol and their comparison |