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CTRI Number  CTRI/2024/10/075002 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   How pre-surgery fasting affects childrens blood sugar, vital signs and feelings of thirst and hunger a study of pediatric elective surgery 
Scientific Title of Study   Impact of Actual Preoperative Fasting Duration on Blood Glucose, Hemodynamics, Child Thirst and Hunger Score in Pediatric Elective Surgery patients: 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  Kamal chitara 
Designation  Consultant Anesthetist  
Affiliation  Medipulse Hospital Jodhpur Rajasthan 
Address  Department of anesthesia, Medipulse hospital Basni second phase AIIMS road Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342001
India 
Phone  7742934887  
Fax    
Email  drkamalkchitara2010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kamal chitara 
Designation  Consultant Anesthetist  
Affiliation  Medipulse Hospital Jodhpur Rajasthan 
Address  Department of anesthesia Medipulse hospital Basni second phase AIIMS road Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342001
India 
Phone  7742934887  
Fax    
Email  drkamalkchitara2010@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kamal chitara 
Designation  Consultant Anesthetist  
Affiliation  Medipulse Hospital Jodhpur Rajasthan 
Address  Department of anesthesia Medipulse hospital Basni second phase AIIMS road Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342001
India 
Phone  7742934887  
Fax    
Email  drkamalkchitara2010@gmail.com  
 
Source of Monetary or Material Support  
Department of anesthesia Medipulse hospital Basni second phase AIIMS road Jodhpur Rajasthan 342001 
 
Primary Sponsor  
Name  Medipulse hospital 
Address  Basni second phase AIIMS road Jodhpur Rajasthan  
Type of Sponsor  Private hospital/clinic 
 
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 
DrKamal chitara  Medipulse hospital  Department of anesthesia first floor
Jodhpur
RAJASTHAN 		 7742934887

drkamalkchitara2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Medipulse hospital Jodhpur Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  No intervention required 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All patients with American Society of Anaesthesiology-Physical Status Grade I or II of either sex, aged between 5 years and 12 years, and undergoing elective surgeries under general anaesthesia, will be included in the study. 
 
ExclusionCriteria 
Details  Refusal of parental consent
Patients undergoing emergency surgery
Patients with increased risk of aspiration eg. patients with full stomach, patients with trache-esophageal fistula, patients with impaired consciousness, patients with swallowing disorders.
History of prematurity, seizures, syndromic babies and congenital heart disease
History of recent upper respiratory tract infection
Patients ASA grade more the 2 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and record actual preoperative fasting hours for clear liquid for the selected children included in the study sample.
 		 Just prior to surgery in preoperative ward
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and record actual preoperative fasting hours for solids and to evaluate children hunger and thirst score and effects on hemodynamics intraoperatively.  Just after induction and then after frequent time interval intraoperatively. 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   20/10/2024 
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="0"
Months="1"
Days="15" 
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   The current guidelines for preoperative fasting recommend intervals of 6, 4, and 2 h (6-4-2) of fasting for solids, breast milk, and clear fluids, respectively. The objective is to minimize the risk of pulmonary aspiration of gastric contents, but also to prevent unnecessarily long fasting intervals.However, despite these clear recommendations, fasting times are often prolonged both in India and globally.]Various factors contribute to non-compliance with guidelines, including organizational issues, communication problems, inadequate understanding of fasting instructions or necessity, intentional misinformation to avoid procedure cancellation, and conflicting instructions from multiple sources. Fasting leads to thirst, hunger and anxiety. Young children are used to eat more often than adults and it is also hard to explain to a small child why they cannot eat. Preoperative fasting may thus lead to additional anxiety and discomfort, in children already anxious because of the hospital environment and preoperative procedures. Not surprisingly, several studies show that children allowed to drink prior to surgery show less thirst, hunger and discomfort, than children that are kept fasting for longer periods.
Considering these studies and results, we planned to conduct a prospective observational study in pediatric population to evaluate actual preoperative fasting and its intraoperative pathophysiological effect.
In this study our aim is to evaluate the actual duration of preoperative fasting and its effect on blood glucose levels and hemodynamics in pediatric population age group 5 to 12 years undergoing elective surgical procedure under general anaesthesia. 
 
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