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CTRI Number  CTRI/2025/09/094301 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 06/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of 10 minute prewarming before surgery on prevention of low body temperature in children 
Scientific Title of Study   Comparison of perioperative hypothermia with and without active short-term prewarming in paediatric patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prajjwal Angrish 
Designation  Junior resident  
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West,New Delhi

South
DELHI
110029
India 
Phone  9805311644  
Fax    
Email  A9805311644@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kavita Rani Sharma 
Designation  Director Professor and Head of Department  
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West,New Delhi

South
DELHI
110029
India 
Phone  9968604376  
Fax    
Email  drkavitadn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kavita Rani Sharma 
Designation  Director Professor and Head of Department  
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West,New Delhi


DELHI
110029
India 
Phone  9968604376  
Fax    
Email  drkavitadn@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia and intensive care, Vardhaman Mahavir medical College and Safdarjung hospital, Ansari Nagar West, New Delhi,India. 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi,India. 110029 
Type of Sponsor  Government medical college 
 
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 Kavita Rani Sharma   Vardhman Mahavir medical college and Safdarjung hospital  operation theater 2, main OT complex, Department of anaesthesia and intensive care, near New emergency building, Ansari nagar West, New Delhi, India 110029 New Delhi DELHI
South
DELHI 
9968604376

drkavitadn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vardhman Mahavir Medical College, New Delhi  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 
Intervention  Active short term prewarming  Application of active forced air warming device for 10 minutes before induction of anaesthesia in paediatric patients undergoing elective surgery. Continuous intraoperative warming with forced air warmer will be used until end of surgery. 
Comparator Agent  No active prewarming.  Patients will receive standard perioperative care without active prewarming before induction. Continuous intraoperative warming with forced air warmer will be used until end of surgery. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All paediatric patients who meet the standards of the American Society of Anaesthesiologists (ASA) grade I, II and aged between 1 to 12 years, undergo elective surgery under general anaesthesia.
Expected Duration of surgery 1 to 3 hours. 
 
ExclusionCriteria 
Details  Preoperative core temperature more than 38°C 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of intraoperative hypothermia (core temperature less than 36°C).  From induction of anaesthesia until end of surgery monitored every 10 minutes intraoperatively.
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of postoperative shivering   It will be measured in post anaesthetic care unit at arrival and at 1 hour post arrival using Wrench scoring system 
Incidence of hypothermia at time of shifting to post anaesthetic care unit.  It will be measured immediately after shifting the patient to the post anaesthetic care unit. 
Core peripheral temperature gradient.  It will be measured at beginning and end of surgery. 
Degree of hypothermia which is duration of hypothermia and fall in temperature during total duration of surgery.  It will be measured at the end of the surgery. 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/10/2025 
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="1"
Months="6"
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  

Perioperative hypothermia defined as a core body temperature below 36C is a significant concern in surgical patients. It occurs in 50 to 90 percent of cases even during minor procedures. It is associated with complications including increased blood loss, higher infection risk, prolonged hospital stays, delayed wound healing and adverse cardiovascular effects. Paediatric patients are more vulnerable due to larger surface area to body mass ratio, less insulating fat, immature thermoregulation and increased heat loss. Despite active warming strategies like forced air

warming blankets, infusion heating and increasing operating room temperature, studies report that nearly 65 percent of patients still develop hypothermia within the first hour of surgery. This is due to redistribution of heat after induction of anaesthesia. Prewarming increases peripheral tissue temperature and reduces redistribution. While traditional guidelines recommend 30 minutes, recent studies show even 10 minutes can be effective. However most existing literature is in adults and data in children is lacking. This study aims to investigate whether a 10 minute active prewarming protocol provides additional benefits for paediatric patients undergoing elective surgery with continuous intraoperative warming. The goal is to optimize perioperative temperature management, reduce incidence of perioperative hypothermia and improve recovery in children aged 1 to 12 years.


 
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