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CTRI Number  CTRI/2024/07/071369 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To know the time since consumption of food and water in children before undergoing surgery and to find out its effect on hunger and thirst in the same period 
Scientific Title of Study   To assess the actual duration of preoperative fasting in paediatric patients undergoing surgeries under general anaesthesia and its effects on hunger and thirst in preoperative period, 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  DrSushama R Tandale 
Designation  Assistant Professor 
Affiliation  BJ Government medical college and Sassoon Hospital ,Pune 
Address  Block 11, First floor, Old hospital building, Department of Anaesthesia , BJ Government medical college and Sassoon Hospital ,Pune MAHARASHTRA
Nursing hostel, Sassoon hospital campus , BJ Government medical college ,Pune MAHARASHTRA
Pune
MAHARASHTRA
411001
India 
Phone  9870253238  
Fax    
Email  docsushma.shitole@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjusree 
Designation  Junior resident  
Affiliation  BJ Government medical college and Sassoon Hospital ,Pune 
Address  Nursing hostel, Sassoon hospital campus, BJ Government medica college, Pune MAHARASHTRA India
Nursing hostel, Sassoon hospital campus, BJ Government medica college, Pune MAHARASHTRA
Pune
MAHARASHTRA
411001
India 
Phone  8220044044  
Fax    
Email  manjusreeravi08@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSushama R Tandale 
Designation  Assistant Professor 
Affiliation  BJ Government medical college and Sassoon Hospital ,Pune 
Address  Block 11, First floor, Old hospital building, Department of Anaesthesia , BJ Government medical college and Sassoon Hospital ,Pune MAHARASHTRA
Nursing hostel, Sassoon hospital campus , BJ medical college, Pune MAHARASHTRA
Pune
MAHARASHTRA
411001
India 
Phone  9870253238  
Fax    
Email  docsushma.shitole@gmail.com  
 
Source of Monetary or Material Support  
Room no.11, Anaesthesia department ,First floor, Old hospital building, BJ government Medical college and sassoon general hospital, Jayaprakash Narayan road, Agarkar nagar, Pune, Maharashtra, 411001, India, Country code 091. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjusree R  BJ Government medical college and Sassoon general hospital  No 17 Paediatric surgery OT 1 and 2 Department of Paediatric surgery second floor Old hospital building BJ Government medical college and Sassoon hospital Jayaprakash Narayan road Agarkar nagar Pune Maharashtra 411001 India
Pune
MAHARASHTRA 
8220044044

manjusreeravi08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BJGMC AND SGH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N37||Urethral disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Age 7 to 12
Either gender
ASA Grade I or II
Elective Surgery
Consent(written informed assent was obtained from participant) 
 
ExclusionCriteria 
Details  Non consent
ASA Grade III and above
Emergency procedure
Fasting due to medical and surgical or medical indication other than preoperative fasting
Neurological impairment
Communication barrier like deaf and mute child 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the actual duration of preoperative fasting in paediatric population and its effects on hunger and thirst  Time since last oral intake of solids or liquids in paediatric patient till the child is just taken inside the operation theatre for induction of anaesthesia
The hunger and thirst score to be assessed when the child is just taken inside operation theatre for induction of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1)To record starvation time to food & clear liquids, hunger score & thirst score preoperatively
2)To find out relation between awake fasting time, administration of intravenous fluid & anaesthesia start time with preoperative hunger & thirst score
3)To know the reasons for unacceptable starvation time preoperatively 
Hunger & thirst score assessed 30 minutes before induction of anaesthesia 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   01/11/2024 
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="1"
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   TITLE OF STUDY
To Assess The Actual Duration Of Preoperative Fasting In Paediatric Patients Undergoing Surgeries Under General Anaesthesia And Its Effects On Hunger And Thirst In Preoperative Period A Prospective Observational Study

INTRODUCTION 
Prolonged preoperative fasting is associated with numerous deleterious effects and stress response to surgery. Multiple anesthesia guidelines from various anesthesia associations have reviewed the preoperative fasting recommendations to reduce prolonged preoperative fasting. Although the guidelines recommend that preoperative fasting for solids and non human milk should be 6 hours and for clear fluids should be 2 hours , the actual fasting times of patients are far from these recommendations. 

AIMS AND OBJECTIVES 

AIM 
To record starvation time to food and clear liquids ,hunger score and thirst score preoperatively 

OBJECTIVES 

To find out relation between awake fasting time ,administration of intravenous fluid and anesthesia start time with preoperative hunger and thirst score 
To know the reason for unacceptable starvation time preoperatively 



MATERIALS AND METHODS  
This will be a prospective , observational study to be carried out at Tertiary care hospital after approval from Hospital Ethical committee and Departmental permission.

SELECTION OF PATIENTS 

Inclusion criteria :
Age 7-12 years
Either gender
ASA Grade I or II
Elective Surgery
Consent (written informed assent was obtained from participant)

Exclusion criteria :
Non consent
ASA Grade III and above
Emergency procedure
Fasting due to medical and surgical or medical indication other than preoperative fasting
Neurological impairment
Communication barrier like deaf and mute child

Pre-anaesthetic Assessment-

Thorough medical and surgical history of the patient, clinical evaluation and details of current
medications will be recorded.

Preoperative Investigations:
-Age, weight and Baseline vital parameters
-Complete blood count, Renal function test, liver function test, serum     electrolytes, PT INR
- General and Systemic Examination
- Written informed consent from parents on the day of surgery

DETAILS OF RESEARCH PLAN : After obtaining institutional Ethics Committee
approval and written informed consent from parents in the language best understood by them,
All parents will be instructed about the fasting guidelines one day prior surgery. Children will be
allowed to fast for 8 hours after full meal,6 hours after snacks and milk and 2 hours after clear
liquid (4 ml/kg). after completion of starvation hours as per guidelines, Child will be started with
administration of ringer lactate intravenous fluid at maintenance rate as per holiday segar
formula
Weight in kg Maintenance fluid (requirement per hour/kg)
<10 kg 4 ml/kg/ hr
10-20 kg 40 ml+2ml/kg for every kg > 10 kg
>20 kg 60 ml+1 ml/kg for every kg>20 kg

After arrival in operation theatre, all participants and their parents will be asked for last time the
participants ate food and drank liquid prior to surgery and the same will be recorded. If
starvation time is beyond the recommended time, then reason for same will be asked eg- sleeping
child, refusal for intake, nausea and pain in child, inadequate parental information about fasting
guidelines, less motivated parents etc. Starvation time is the time between their last oral intake
and start of general anaesthesia. Starvation time when child is in awake state after night sleep
will also be noted. Maintenance fluid received by the participants will also be noted. Hunger and
thirst score will be assessed for participants just prior shifting patient to operation theatre.

Hunger score and Thirst score will be self-rated using a 0 to10 scale (0 is feeling not hungry or
thirsty, 10 is feeling extremely hungry or thirsty) by the participants. Unacceptable starvation time
is defined as a starvation time more than two times the recommended fasting duration. Therefore,
the unacceptable fasting duration for full meal, snacks and clear water will be more than 16 hours,12 hours and 4 hrs respectively.


 
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