| CTRI Number |
CTRI/2025/10/096495 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding and measuring how children feel and get back to normal after same day surgery in India |
|
Scientific Title of Study
|
A Prospective Observational Study to Assess the Quality of Recovery in Children Undergoing Elective Day Care Surgeries in a Tertiary Care Hospital in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmita Bairagi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
09953060597 |
| Fax |
|
| Email |
sushmita.bairagi91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushmita Bairagi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
09953060597 |
| Fax |
|
| Email |
sushmita.bairagi91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushmita Bairagi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
09953060597 |
| Fax |
|
| Email |
sushmita.bairagi91@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India, 110029 |
| 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 |
| Dr Sushmita Bairagi |
AIIMS, New Delhi |
Department of Anesthesiology, Pediatric Operation theatre no 13,14,15, AIIMS, New Delhi,110029
South West
DELHI |
09953060597
sushmita.bairagi91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R10-R19||Symptoms and signs involving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Children aged 2–12 years of either gender
2)Scheduled for elective day care surgery.
3)Patients belonging to American Society of Anaesthesiologists’ Physical Status Grade I or II
4)Guardians giving wilful consent for the participation in the study
|
|
| ExclusionCriteria |
| Details |
1)Developmental delay or cognitive impairment.
2)Emergency surgeries.
3)Patient/Guardian refusal.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean total score on the Pediatric Scale for Quality of Recovery (PedSQoR) assessed at 2–4 hours after surgery |
at 2 hrs and 4 hrs post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess associations between demographic/clinical factors (age, type of surgery, duration, ASA status) and PedSQoR scores
• To evaluate parental satisfaction at 2-4 hours post-discharge
• To document any early postoperative complications
|
at 2 hrs and at 4 hrs post surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
16/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
This is a single-arm, prospective, cross-sectional observational study conducted at a tertiary care hospital in India to evaluate the early quality of recovery in children undergoing elective day care surgery. Eligible patients aged 2–18 years will be recruited preoperatively, and baseline demographic and clinical data will be recorded. Postoperative recovery will be assessed 2–4 hours after surgery using the validated Pediatric Scale for Quality of Recovery (PedSQoR), along with a parental satisfaction survey. Associations between recovery scores and surgical/anesthetic variables will be explored, and early postoperative complications such as vomiting, agitation, and delayed feeding will be documented. The findings aim to provide evidence to refine discharge criteria and improve perioperative care for pediatric day care surgery in the Indian context. |