| CTRI Number |
CTRI/2024/10/076086 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how fasting to solid and liquid intake before surgery impact the blood sugar values in children who undergoes cleft lip and cleft palate repair. |
Scientific Title of Study
Modification(s)
|
Preoperative fasting practices and their association with hypoglycemia in children undergoing cleft lip and/or cleft palate surgery- A prospective observational analytical cohort 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 |
MOHINI SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical care, 2nd floor, Institute Block, JIPMER, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6006028591 |
| Fax |
|
| Email |
skalanderia279@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PANKAJ KUNDRA |
| Designation |
PROFESSOR |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care, 2nd floor, Institute block, JIPMER, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9367602030 |
| Fax |
|
| Email |
P_KUNDRA@HOTMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
MOHINI SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical care, 2nd floor, Institute block, JIPMER, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6006028591 |
| Fax |
|
| Email |
skalanderia279@gmail.com |
|
|
Source of Monetary or Material Support
|
| institute research fund
jipmer, JIPMER, Puducherry,605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER INTRAMURAL FUNDING |
| Address |
Administration block, first floor, JIPMER,PUDUCHERRY,605006 |
| 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 Mohini sharma |
JIPMER |
Institute block, second floor,
Department of Anesthesiology and critical care, JIPMER, Puducherry,605006
jipmer
Pondicherry
PONDICHERRY |
6006028591
skalanderia279@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(HUMAN STUDIES),JIPMER, PUDUCHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M269||Dentofacial anomaly, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children under 5 of years undergoing cleft lip and cleft palate repair. |
|
| ExclusionCriteria |
| Details |
1)Parent(s) refusal to enrol their children as a participant as a study. 2)Children receiving preoperative intravenous fluids. 3)Children on steroids or insulin. 4)Children with metabolic disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of low blood glucose levels (blood glucose less than 70mg/dl), hypoglycemia(less than 60mg/dl), incidence of increased ketones (more than 0.6mmol/L) |
Baseline and after induction of general anaesthesia |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Association between fasting duration & blood glucose levels |
Preoperative & after induction of general anaesthesia |
| Association between compliance with fasting guidelines & blood glucose levels |
Preoperative & after induction of general anaesthesia |
| To record the reasons for non-compliance to standards preoperative fasting guidelines using printed questionnaire. |
Before shifting the patient to operation theatre |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/11/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
After obtaining approval from the Departmental Postgraduate Research Monitoring Committee (PGRMC) and Institute Ethics Committee (IEC), children below 5 years of age scheduled for elective cleft lip and/or palate surgery will be recruited for this study. Parental written consent will be taken during the preoperative assessment one day prior to scheduled elective surgery. Demographic details (name, age, gender, weight, place of residence, hospital number and diagnosis) will be recorded. General nutritional status (height, weight, mid-arm circumference) will be assessed. In addition, baseline haemoglobin and random capillary blood glucose levels will be recorded preoperatively. On the day before the surgery, parents will receive a pictographic pamphlet representing standard pediatric preoperative fasting guidelines viz 8 hours for solids, 6 hours for non-human formula milk, 4 hours for breast milk and 2 hours for clear fluids. Parents will be explained the fasting orders in their own native language and instructed to record the last feeding time. Random capillary blood glucose level assessment will be done using a glucometer and the data obtained will be documented. Premedication will be given at the discretion of the attending consultant. On the day of surgery, upon arrival in the operation theatre, the accompanying nurse and parents will be interviewed in the preoperative holding area regarding the time and quantity of the child last solid and liquid intake, and the pamphlet will be collected. If there is evidence of deviation from standard preoperative guidelines (instructions given), the cause behind the deviation will be recorded. In the operation theatre, after induction of anaesthesia, capillary blood glucose level will be recorded using the same glucometer and ketone bodies will be recorded by ketone meter. Low blood glucose is defined as blood glucose value less than 70mg/dl. Hypoglycemia is defined as blood glucose less than 60 mg/ dl; if present, it will be treated as per standard treatment protocol (administration of 10% dextrose 2ml/kg ). Blood glucose will be checked after 15 minutes and once the blood glucose attains normal level, surgery will be initiated. Ketosis is defined as a blood ketone body level of more than 0.6 mmol/L; if present, dextrose 1% along with normal saline will be given throughout the intraoperative period.
Following parameters will be assessed: Age sex height weight mean fasting duration fasting duration for solid / formula feeds fasting duration for breast milk fasting duration for clear liquid Blood glucose levels Blood ketone bodies level deviation from the recommended duration association between preoperative fasting duration and capillary blood glucose levels association between compliance with standard preoperative fasting guidelines and capillary blood glucose levels reasons for deviation hemodynamic parameters
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