| CTRI Number |
CTRI/2024/09/073328 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the best propofol dose for producing loss of consciousness among different weight metrics. |
|
Scientific Title of Study
|
A prospective observational study on correlation of induction dose of propofol according to different body weight metrics. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dusu Lalin |
| Designation |
Assistant Professor |
| Affiliation |
Tomo Riba Institute of Health and Medical Sciences. |
| Address |
Department of Anaesthesiology
2nd floor, block 1.
TRIHMS, Naharlagun.
Papum Pare
ARUNACHAL PRADESH
791110
India |
| Phone |
7367967439 |
| Fax |
|
| Email |
drdusulalin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dusu Lalin |
| Designation |
Assistant Professor |
| Affiliation |
Tomo Riba Institute of Health and Medical Sciences. |
| Address |
Department of Anaesthesiology
2nd floor, block 1.
TRIHMS, Naharlagun.
Papum Pare
ARUNACHAL PRADESH
791110
India |
| Phone |
7367967439 |
| Fax |
|
| Email |
drdusulalin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dusu Lalin |
| Designation |
Assistant Professor |
| Affiliation |
Tomo Riba Institute of Health and Medical Sciences. |
| Address |
Department of Anaesthesiology
2nd floor, block 1.
TRIHMS, Naharlagun.
Papum Pare
ARUNACHAL PRADESH
791110
India |
| Phone |
7367967439 |
| Fax |
|
| Email |
drdusulalin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, TRIHMS, Naharlagun,Arunachal Pradesh, India -791110 |
|
|
Primary Sponsor
|
| Name |
TRIHMS |
| Address |
Department of Anaesthesiology
2nd floor, block 1, TRIHMS, Naharlagun. |
| 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 |
| Dr Dusu Lalin |
TRIHMS |
Department of Anaesthesiology,2nd floor old building
TRIHMS, Naharlagun
Papum Pare
ARUNACHAL PRADESH |
7367967439
drdusulalin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tomo Riba Institute of Health and Medical Sciences. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
posted for elective surgery |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA-PS I & II
ROUTINE SURGERY CASE UNDER GENERAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
UNCONTROLLED HYPERTENSION
ISCHEMIC HEART DISEASE
RENAL OR HEPATIC DYSFUNCTION
SUSPECTED SUBSTANCE ABUSE. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the best propofol induction dose among different body weight metrics. |
during induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any serious adverse event. |
During induction period. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/09/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective observational study on the correlation of induction dose of propofol according to different body weight metrics going to be done on 40 patients in patients undergoing elective surgery. |