| CTRI Number |
CTRI/2024/07/070342 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Delirium in children following surgery and its factors |
|
Scientific Title of Study
|
Incidence of hypoactive emergence delirium in the paediatric population and its correlation with perioperative factors: A prospective, observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asna Jamal |
| Designation |
Resident, MD Anaesthesia |
| Affiliation |
Hamdard Institute of Medical Sciences and Research |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B- Block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
8860955920 |
| Fax |
|
| Email |
asnawarsi96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotsna Agarwal |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Hamdard Institute of Medical Sciences and Research |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B- block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
9650252828 |
| Fax |
|
| Email |
jyotsna.doctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asna Jamal |
| Designation |
Resident, MD Anaesthesia |
| Affiliation |
Hamdard Institute of Medical Sciences and Research |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B- Block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
8860955920 |
| Fax |
|
| Email |
asnawarsi96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hamdard Institute of Medical Sciences and Research and HAHC Hospital |
|
|
Primary Sponsor
|
| Name |
Hamdard Institute of Medical Sciences and Research |
| Address |
Hamdard Institute of Medical Sciences and Research and HAHC hospital, Hamdard Nagar, New Delhi, 110062 |
| Type of Sponsor |
Private 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 Asna Jamal |
Hamdard Institute of Medical Sciences and Research and HAHC Hospital |
Operation theatre, 8th Floor, B- block, New Hospital Building, Hamdard Institute of Medical Sciences and Research and Hakeem Abdul Hameed Centenary Hospital, Hamdard Nagar 110062
South
DELHI |
8860955920
asnawarsi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Hamdard Institute of Medical Sciences & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All patients up to 18 years of age, with American Society of Anaesthesiologist (ASA)
physical status I-II posted for surgery |
|
| ExclusionCriteria |
| Details |
1. Patient or parent refusal
2. Patient planned for surgery exclusively under regional anesthesia
3. Patients with liver or renal insufficiency
4. Patients with any active systemic infection or disease
5. Patients with neurological or psychiatric disorders
6. Patients with prior opioid addiction
7. Patients with deafness, blindness or other sensory deficit
8. Patients with any known congenital anomalies.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To calculate the incidence of hypoactive emergence delirium (ED) by finding the
additional yield of CAP-D score over PAED score in pediatric patients.
|
Scores will be given at the completion of childs stay in post anesthesia care unit (PACU). The child will be discharged from PACU after 45 minutes of PACU stay or on achieving Modified Aldrete Score of 9 or more whichever is later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To calculate the incidence of hypoactive emergence delirium by finding the
additional yield of CAP-D score over PAED score in pediatric patients |
To study the correlation between hypoactive emergence delirium & anaesthesia technique,patient & surgical factors |
|
|
Target Sample Size
|
Total Sample Size="145"
Sample Size from India="145"
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)
|
22/07/2024 |
| 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="6"
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 study is a prospective, observational study, to determine the incidence of hypoactive delirium in paediatric surgical patients in our hospital and correlate it with anaesthesia factors, surgical factors and patient factors. The incidence of hypoactive delirium will be found by calculating the additional yield of CAPD scale over PAED scale. The objectives of the study are- 1) To calculate the incidence of hypoactive emergence delirium by finding the additional yield of CAPD score over PAED score in paediatric patients 2)To study the correlation between hypoactive ED and anaesthesia technique.
3)To study the correlation between hypoactive ED and patients factors (age, gender, pre-operative anxiety, preoperative fasting, postoperative pain).
4)To study the correlation between hypoactive ED and surgical factors (type of surgery, duration of surgery). The trial is conducted in a single centre in the operation theatres of Hamdard Institute of Medical Sciences and Research. |