| CTRI Number |
CTRI/2023/01/048808 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
16/01/2023 |
| 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
|
To Compare The Dose Of Propofol Drug For Induction Of General Anaesthesia As Determined By Entropy Monitoring Against The Standard Induction Dose In Elderly Patients |
|
Scientific Title of Study
|
To Compare The Dose Of Propofol For Induction Of General Anaesthesia As Determined By Entropy Monitoring Against The Standard Induction Dose In Elderly Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhavi Buddhi |
| Designation |
Associate Professor |
| Affiliation |
Seth G.S.Medical College & KEM Hospital |
| Address |
Anesthesia department first floor old building near room no 53 kem hospital
Acharya Donde Marg,Parel East,
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
9969105307 |
| Fax |
|
| Email |
madhavi_70@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhavi Buddhi |
| Designation |
Associate Professor |
| Affiliation |
Seth G.S.Medical College & KEM Hospital |
| Address |
First floor old building near room no 53 Anesthesia department kem hospital
Acharya Donde Marg,Parel East,
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
9969105307 |
| Fax |
|
| Email |
madhavi_70@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhavi Buddhi |
| Designation |
Associate Professor |
| Affiliation |
Seth G.S.Medical College & KEM Hospital |
| Address |
Anesthesia department first floor old building near room no 53 kem hospital
Acharya Donde Marg,Parel East,
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
9969105307 |
| Fax |
|
| Email |
madhavi_70@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Seth GSMC and KEM hospital |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [] |
|
|
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 |
| Madhavi Buddhi |
Seth GS medical college and kem hospital |
First floor old building near room no 53 Anesthesia department kem hospital
Mumbai (Suburban)
MAHARASHTRA |
9082113320
syama35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
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 |
| Intervention |
Giving propofol based on entropy monitoring during induction in elderly patients |
Entropy group will receive propofol based on entropy reading till RE and SE value comes to 40 to 60.Control group will receive propofol based on weight.Given intravenously propofol will be given at 30 mg every 15 seconds each till RE ,SE value comes between 40 to 60 and RE-SE value comes less than 10 in entropy group while propofol given intravenously based on weight in control group. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients in age group more than 50 years of either sex belonging to American Society of Anesthesiologist 1&2 |
|
| ExclusionCriteria |
| Details |
1.Patients who have history of allergy to propfol.2.patients with history of cardiac disease.3.ASA 3 and ASA 4 STATUS patients.4.long term use of drugs affecting the central nervous system. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know whether there is decrease in requirements of propofol during induction of general Anesthesia in elderly patients. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the haemodynamic stability of the patients |
To record systolic Blood pressure,diastolic blood pressure,mean blood pressure,heart rate at baseline,after induction.after intubation at 1 minute. |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
09/01/2023 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Propofol is the most common intravenous anaesthetic agent used for induction of general Anesthesia.Standard practice is always cautious and anesthestist always tend to give larger doses than the required to avoid awareness which is terrific.As age increases there is reduced hepatic blood flow and reduction in liver mass which decreases the clearance of propofol and increases the risk of cardiovascular adverse effects such as hypotension.Entropy monitoring is method to analyse depth of Anesthesia done by hypnotic drugs through EEG ,EMG.It has two parameters ,RE (response entropy)which includes EEG and EMG.SE(state entropy) includes EEG .Target range for adequate depth is 40 to 60band difference between RE and SE is less than 10.So by giving propofol based on entropy monitoring will not only avoid giving excessive deepening of Anesthesia.So giving propofol during induction of general Anesthesia based on entropy is a useful tool to give adequate depth and maintaining haemodynamic stability of elderly patients. |