| CTRI Number |
CTRI/2025/03/083427 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study regarding the assessment of confusion state and irritability post anaesthesia recovery in children who will undergo surgery. |
|
Scientific Title of Study
|
A cross -sectional study of emergence delirium in paediatric patients undergoing elective surgery in a tertiary care centre in Chengalpet district |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maria Antony Surya A |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai medical college and research institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai medical college hospital and research institute Thiruporur,Guduvanchery main road , Ammapettai, Nellikuppam
Kancheepuram
Tamilnadu
603108
India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9894385582 |
| Fax |
|
| Email |
surya2831997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anusha Balasubramanian |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai medical college and research institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai medical college hospital and research institute Thiruporur,Guduvanchery main road , Ammapettai, Nellikuppam
Kancheepuram
Tamilnadu
603108
India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9003738506 |
| Fax |
|
| Email |
anusha14scorpio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maria Antony Surya A |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai medical college and research institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai medical college hospital and research institute Thiruporur,Guduvanchery main road , Ammapettai, Nellikuppam
Kancheepuram
Tamilnadu
603108
India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9894385582 |
| Fax |
|
| Email |
surya2831997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai medical college hospital and research institute, Thiruporur - Guduvanchery main road ,Ammapettai ,Nellikuppam
Kancheepuram -Tamilnadu
603108 |
|
|
Primary Sponsor
|
| Name |
Dr Maria Antony Surya A |
| Address |
8/3 seevalaperi road
Palayamkottai
Tirunelveli -627002 |
| 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 |
| Dr Maria Antony SuryaA |
Shri Sathya Sai medical college and research institute |
Department of Anaesthesiology, 2nd floor OT complex
Shri Sathya Sai medical college , Thiruporur Guduvanchery main road , Ammapettai , Kancheepuram
Kancheepuram
TAMIL NADU |
9894385582
surya2831997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Sathya Sai medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female children of age 3 -18 years belonging to ASA grade 1&2,posted for GA |
|
| ExclusionCriteria |
| Details |
Patients with ASA grade 1
Patients with lower respiratory tract infection
Patients with CNS abnormalities and congenital abnormalities
Mentally challenged |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - To predict the incidence of emergence delirium in children using PAEDIATRIC scale and FACES scale |
Post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| - To study the incidence of post operative nausea and vomiting |
Post operatively |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
26/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
This is a cross sectional study of emergence delirium in paediatric patients undergoing elective surgery in a tertiary care centre Chengelpet district over a period of 18 months . Primary objective of the study is to predict the prevalence of emergence delirium in children using PAED scale and FACES scale Secondary objective of the study is to study the incidence of postoperative nausea and vomiting |