| CTRI Number |
CTRI/2025/02/080631 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Link Between Pre-Operative Health and Post-Anesthesia Cognitive Outcomes in Children |
|
Scientific Title of Study
|
Determining the association between pre-operative frailty and nutritional status with the occurrence of emergence delirium and cognitive dysfunction in pediatric patients under general anesthesia. |
| 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 puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room No. 5008A, Main Building,
teaching Block,
Department of Anesthesiology, Pain Medicine and Critical care,
AIIMS, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
09873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room No. 5008A, Main Building,
teaching Block,
Department of Anesthesiology, Pain Medicine and Critical care,
AIIMS, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
09873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room No. 5008A, Main Building,
teaching Block,
Department of Anesthesiology, Pain Medicine and Critical care,
AIIMS, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
09873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
All India Institute of Medical Sciences, Ansari Nagar, New Delhi, New Delhi, India - 110029 |
|
|
Primary Sponsor
|
| Name |
Dr. Puneet Khanna |
| Address |
Room No. 5008A, Main Building, Teaching Block,
Department of Anesthesiology, Pain Medicine and Critical Care,
AIIMS, New Delhi 110029 |
| Type of Sponsor |
Other [] |
|
|
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 Puneet Khanna |
All India Institute of Medical Sciences |
Room No. 5008A, Main Building,
teaching Block,
Department of Anesthesiology, Pain Medicine and Critical Care,
AIIMS, Ansari Nagar, New Delhi
South West
DELHI |
09873106516
k.punit@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1) Pediatric patients under the age of 2 -17 years who will be scheduled for surgery under
GA will be included.
2) Parents or legal guardians of pediatric patients who provide written informed consent will
be eligible for inclusion.
3) Patients with a baseline Glasgow Coma Scale score of 15/15 and an expected duration of
surgery exceeding 60 minutes will be included. |
|
| ExclusionCriteria |
| Details |
1) History suggestive of dementia (either listed in the medical record or reported by the
patient) or any neurological disorder
2) History of any cerebral surgeries
3) History suggestive of psychiatric disease like schizophrenia, dementia, anxiety or other
disorder affecting cognition, mental dysfunction
4) Prescription of central nervous system active medication (eg: antidepressants,
antipsychotics, sedatives) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.) Nutritional Status
2.) Sarcopenia
3.) Frailty Score
4.) Paediatric anaesthesia emergence delirium
5.) Post operative cognitive dysfunction. |
1.) 24 hours preoperative
2.) Postoperative 30 minutes, 24 hours and 48 hours
3.) Follow up 1 week, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.) Post operative cognitive dysfunction for follow-up time periods scheduled for 1 week, 3 months, and 6 months. (Through telephonic discussion). |
1 week, 3 months, and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
03/03/2025 |
| 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="3"
Months="0"
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 investigation is to examine the complex interplay of malnutrition, frailty, and their impact on paediatric health outcomes [1]. Recognizing the severity of malnutrition, prestigious organizations such as the European Society for Clinical Nutrition and Metabolism at Risk (ESPEN) and the European Society for Gastroenterology, Hepatology, and Nutrition (ESPGHAN) recommend for screening at admission [2-4]. This proactive method aims to identify nutritionally at-risk children, enabling for the development of personalized nutritional support treatment plans. The study focuses to the complex interaction between malnutrition and sarcopenia, as well as body habitus abnormalities such sarcopenic obesity (SO) in children. Studies across diverse clinical populations in adults have shown the increased risks associated with SO, emphasizing the limitations of using BMI as a sole nutritional indicator. Frailty assessments and risk stratification, particularly preoperatively, have been recognized as crucial tools for effective patient care planning and critical care resource utilization. study expands to the prevalence of emergence delirium (ED) and postoperative cognitive dysfunction (POCD) in pediatric anesthesia as Current data suggests that the occurrence of ED varies widely, ranging from 20% to 80% of all pediatric anesthesia cases, though the majority of literature suggests a prevalence closer to 20% and the reported incidence rate of postoperative cognitive dysfunction (POCD) in this population varies from 6.6% to 67%. It is essential, however, to extend our focus to children, whose developing brains may also be susceptible to ED and cognitive alterations. In conclusion, this comprehensive strategy aims to improve the understanding of the synergistic effects of malnutrition and frailty on development delirium and cognitive impairment in pediatric health care. By shedding light on potential interventions and strategies, the study aims to improve patient outcomes, reduce complications, and increase overall well-being for pediatric patients facing a variety of medical difficulties. The multidimensional approach deals with essential aspects of pediatric health, emphasizing the value of proactive measurements, detailed evaluations, and individualized interventions for the best patient care. Ref: [1] Mehta N.M., Corkins M.R., Lyman B., Malone A., Goday P.S., Carney L.N., MonczkaJ.L., Plogsted S.W., Schwenk W.F. Defining pediatric malnutrition: A paradigm shift toward etiology-related definitions. JPEN J. Parenter. Enteral Nutr. 2013;37:460–481. doi: 10.1177/014860711347997 [2] Agostoni C., Axelson I., Colomb V., Goulet O., Koletzko B., Michaelsen K.F., Puntis J.W., Rigo J., Shamir R., Szajewska H., et al. ESPGHAN Committee on Nutrition; European Society for Paediatric Gastroenterology. The need for nutrition support teams in pediatric units: A commentary by the ESPGHAN committee on nutrition. J. Pediatr. Gastroenterol. Nutr. 2005;41:8–11. doi: 10.1097/01.MPG.0000163735.92142.87. [3] Teixeira A.F., Viana K.D. Nutritional screening in hospitalized pediatric patients: A systematic review. J. Pediatr. 2016;92:343–352. doi: 10.1016/j.jped.2015.08.011. [4] Rinninella E., Ruggiero A., Maurizi P., Triarico S., Cintoni M., Mele M.C. Clinical tools to assess nutritional risk and malnutrition in hospitalized children and adolescents. Eur. Rev. Med. Pharmacol. Sci. 2017;21:2690–2701. |