| CTRI Number |
CTRI/2024/07/070673 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of recorded mothers voice on delirium after surgery in children |
|
Scientific Title of Study
|
Effect of recorded mothers voice on postoperative emergence delirium in paediatric patients |
| 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 Sarath Mohan T |
| Designation |
1st year PG Resident |
| Affiliation |
ESIC Medical College and Hospital Faridabad |
| Address |
Department of anaesthesia
3rd floor OT complex
ESIC Medical College and Hospital, Faridabad
NH-3,KL Mehta Rd, behind BK Hospital, New Industrial Township, Faridabad, Haryana
Faridabad
HARYANA
121012
India |
| Phone |
8075751892 |
| Fax |
|
| Email |
sarath1995mohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Virmani |
| Designation |
Professor and Head |
| Affiliation |
ESIC Medical College and Hospital Faridabad |
| Address |
Department of anaesthesia
3rd floor OT complex
ESIC Medical College and Hospital, Faridabad
NH-3,KL Mehta Rd, behind BK Hospital, New Industrial Township, Faridabad, Haryana
Faridabad
HARYANA
121012
India |
| Phone |
9654959719 |
| Fax |
|
| Email |
rashmi.virmani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Virmani |
| Designation |
Professor and Head |
| Affiliation |
ESIC Medical College and Hospital Faridabad |
| Address |
Department of anaesthesia
3rd floor OT complex
ESIC Medical College and Hospital, Faridabad
NH-3,KL Mehta Rd, behind BK Hospital, New Industrial Township, Faridabad, Haryana
Faridabad
HARYANA
121012
India |
| Phone |
9654959719 |
| Fax |
|
| Email |
rashmi.virmani@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital NH3, NIT Faridabad 121012 Haryana India |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital Faridabad |
| Address |
NH-3,KL Mehta Rd, behind BK Hospital, New Industrial Township, Faridabad, Haryana
PIN:121012 |
| 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 Sarath Mohan T |
ESIC Medical College and Hospital,NH3 NIT Faridabad121012 Haryana |
OT Complex
Department of Anaesthesiology
Faridabad
HARYANA |
8075751892
sarath1995mohan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee ESIC Medical College and Hospital NH3 NIT, Faridabad Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
effect of empty track on postoperative emergence delirium in paediatric patients. |
empty track will be played in childrens ears using headphones in perioperative period |
| Intervention |
effect of recorded mothers voice on postoperative emergence delirium in paediatric patients. |
recorded mothers voice will be played in children ears with the headphones in perioperative period |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 2-8years of ASA physical status I or II posted for surgery under general anaesthesia will be included in study. |
|
| ExclusionCriteria |
| Details |
children with neurological disorders.
children with development delays.
children with hearing impairments.
children not accompanied with mother. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of emergence delirium |
Every 10 minutes till 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of recorded mothers voice on preoperative anxiety in children before induction of general anaesthesia.
Acceptance of the anaesthesia face mask by the child during inhalational induction.
Incidence of emergence delirium at different time interval in PACU.
To assess post operative pain in children at various time interval in PACU. |
Every 10 minutes till 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
25/07/2024 |
| 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="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
|
Emergence delirium is an acute confusion state in patients emerging from general anaesthesia.T he incidence of emergence delirium in paediatric patients after general anaesthesia is reported to be ranging from 10% to 80%. It is characterised by being in a dissociated condition of consciousness in which child is irritable, uncoperative, uncompromising and inconsolably crying, moaning, kicking or thrashing. Not many indian studies are available on this topic. |