| CTRI Number |
CTRI/2025/03/081890 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Low blood glucose due to fasting in children under 5 years of age receiving anesthesia during MRI scan. |
|
Scientific Title of Study
|
To assess the impact of preprocedural fasting on blood glucose levels in children undergoing non-operating room anesthesia (NORA) for elective diagnostic radiological procedures on outpatient basis- A Cross-Sectional Analytical 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 |
Shriram Sudarshan Mahabal |
| Designation |
MBBS Intern |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research, Puducherry |
| Address |
Office of the Department of Anesthesiology and Critical Care, 2nd floor, Main hospital block, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9823168968 |
| Fax |
|
| Email |
shriram8mahabal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pankaj Kundra |
| Designation |
Professor of Anaesthesiology and Critical Care |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research, Puducherry |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal institute of postgraduate medical education and research, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9367602030 |
| Fax |
|
| Email |
p_kundra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shriram Sudarshan Mahabal |
| Designation |
MBBS Intern |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research, Puducherry |
| Address |
Office of the Department of Anesthesiology and Critical Care, 2nd floor, Main hospital block, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9823168968 |
| Fax |
|
| Email |
shriram8mahabal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantari Nagar, Puducherry, Puducherry, India, 605006 |
|
|
Primary Sponsor
|
| Name |
Dr Shriram Sudarshan Mahabal |
| Address |
41, Vasant Vihar, Baner, Pune, Maharashtra, India 411045 |
| Type of Sponsor |
Other [Principal Investigator initiated study] |
|
|
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 Shriram Mahabal |
Jawaharlal institute of postgraduate medical education and research, Puducherry |
3T MRI suite, Ground floor, Super specialty block annexe, Department of Radiodiagnosis
Pondicherry
PONDICHERRY |
9823168968
shriram8mahabal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES DHR REG. N0. ECNEW/INST/2020/331 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children 5 years and under undergoing non-operating room anaesthesia for elective diagnostic radiological procedures on an outpatient basis in JIPMER. |
|
| ExclusionCriteria |
| Details |
Children on preoperative intravenous fluids.
Children receiving medications known to alter blood sugar values.
Children with known metabolic disorders.
Parent(s) refusal to enroll their children as a participant in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Capillary blood glucose levels in children 5 years of age and under who have met 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting and who and undergoing MRI scan under sedation |
Just prior to patient entering the MRI room. Approximately 2-5 minutes pre-procedurally. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If child presents to the MRI suite & has not met fasting guidelines, the reason for their non- compliance to the ASA 2023 fasting guidelines will be recorded |
At baseline. |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
Final Enrollment numbers achieved (Total)= "174"
Final Enrollment numbers achieved (India)="174" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Prolonged fasting can
cause significant discomfort in paediatric patients, leading to irritability,
dehydration, and other physiological stress responses.Studies
report that the incidence of hypoglycaemia in children who fast for prolonged
periods ranges from 3% to 12%, even in healthy individuals. A
study by Theodor S. Sigurdsson and colleagues examined 300 children with a mean
age of 6.4 years undergoing elective procedures. It found that 12.3%
experienced hypoglycaemia, with the lowest blood glucose level recorded at 1.6
mmol/L. These
findings are critical, as untreated hypoglycaemia can result in serious
complications such as seizures, neurological damage, and in rare cases, death.
The
effect of fasting guidelines on blood glucose levels in children receiving NORA
remains under-researched. This study aims to assess hypoglycaemia incidence and
explore the reasons for fasting guideline non-compliance, ultimately helping
improve safety protocols and reduce fasting-related complications in paediatric
anaesthesia. Primary
objective- To assess the incidence of capillary low blood glucose (less than 70
mg/dl) levels using point of care glucometer among children receiving non-
operating room anaesthesia for diagnostic radiological procedures on outpatient
basis.
Secondary
objective- To identify the reasons for non-compliance to standard fasting
guidelines by usage of a printed questionnaire. |