| CTRI Number |
CTRI/2024/07/071754 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Application device ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of an Application for Anaesthetist for Drug dose and toxic dose calculation Versus Conventional Methods for Pediatric Drug Dose Calculation in general anesthesia |
|
Scientific Title of Study
|
Comparative study of an Application for Anaesthetist for Drug dose and toxic dose calculation Versus Conventional Methods for Pediatric Drug Dose Calculation in general anesthesia - A Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vidya saranya S |
| Designation |
POST GRADUATE ( JUNIOR RESIDENT ) |
| Affiliation |
saveetha medical college and hospital |
| Address |
Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu.
Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7899863830 |
| Fax |
|
| Email |
vidyasharanya12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PONNAMBALA NAMASIVAYAM S |
| Designation |
PROFESSOR |
| Affiliation |
saveetha medical college and hospital |
| Address |
SAVEETHA MEDICAL COLLEGE Saveetha Nagar, Thandalam, Chennai Bengaluru NH 48, Chennai, Tamil Nadu.
SAVEETHA MEDICAL COLLEGE Saveetha Nagar, Thandalam, Chennai Bengaluru NH 48, Chennai, Tamil Nadu.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9444451853 |
| Fax |
|
| Email |
ms.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
PONNAMBALA NAMASIVAYAM S |
| Designation |
professor |
| Affiliation |
saveetha medical college and hospital |
| Address |
SAVEETHA MEDICAL COLLEGE Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu.
Kancheepuram
TAMIL NADU
605102
India |
| Phone |
9444451853 |
| Fax |
|
| Email |
ms.smc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| saveetha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
saveetha medical college and hospital |
| Address |
Department of anesthesiology
saveetha medical college and hospital Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| vidya saranya s |
saveetha medical college and hospital |
department of anaesthesiology
saveetha medical college and hospital
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Kancheepuram
TAMIL NADU |
7899863830
vidyasharanya12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha medical college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anaesthesiology residents and opertation theatre technician students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional method of drug dose calculation |
The traditional approach was figuring out dosages with a calculator, prescription dosage charts, books. |
| Intervention |
Drug dose calculation application |
an Android application tailored for anesthetists marks a pivotal advancement in healthcare technology aimed at addressing these challenges. This application is designed to streamline and optimize drug dosage calculations specifically for paediatric patients, leveraging parameters such as age and weight to tailor dosages accurately |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Anesthesiology residents and operation theatre technician students trained in anesthesia |
|
| ExclusionCriteria |
| Details |
1. No other departments included
2. Anesthesia Consultants
3. OT Nursing staff
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to calculate the drug by the participants . |
Time taken to calculate the drug by the participants within 10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Comfort of the anesthesiologist (5 point Likert scale) |
NOT APPLICAPLE |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2024 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The participants will be presented with paper based written exercises in which they will have to respond to specific scenarios of Paediatric patients undergoing general anaesthesia for drug dosing calculations using either conventional or application assisted methods. Participants in each group should return after 7-10 days to repeat the scenarios- based written exercises using the other method. The time taken by each participants will be noted using a stopwatch. The traditional approach was figuring out dosages with a calculator, prescription dosage charts, books. The application that came with dose formulas pre-loaded and a blank block for each person’s body weight allowed for instantaneous dosage computation in the application-based method of dosing calculation. The usage of application was taught to each participant. The time taken to calculate the drug dosages was measured and the comfort of the participants was assessed (likert scale). |