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CTRI Number  CTRI/2021/10/037208 [Registered on: 08/10/2021] Trial Registered Prospectively
Last Modified On: 06/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Does carbohydrate loading help maintain temperature homeostasis in children during surgery 
Scientific Title of Study   Preoperative carbohydrate loading to maintain normothermia in children under anaesthesia : A prospective randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Neerja Bhardwaj 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care
Level 4, Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  7087009521  
Fax    
Email  neerja.bhardwaj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Neerja Bhardwaj 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care
Level 4, Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  7087009521  
Fax    
Email  neerja.bhardwaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Neerja Bhardwaj 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care
Level 4, Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  7087009521  
Fax    
Email  neerja.bhardwaj@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Neerja Bhardwaj Department of Anaesthesia and Intensive Care 
Address  Room No 6, Faculty offices, Level 2, Nehru Hospital, PGIMER, Chandigarh-160012 
Type of Sponsor  Research institution and hospital 
 
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 
Neerja Bhardwaj  Postgraduate Institute of Medical Education and Research  Operation Theatre, Level 6, Block-A, Advanced Pediatric Centre, PGIMER, Chandigarh-160012
Chandigarh
CHANDIGARH 		 7087009521

neerja.bhardwaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER  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  Glucon - D  5 ml/kg of 12.6 % solution, orally, given only once 2 hours prior to surgery 
Comparator Agent  Plain water  5 ml/kg, orally, given only once 2 hours prior to surgery 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Surgery lasting for more than 30 minutes to less than 3 hours 
 
ExclusionCriteria 
Details  Laparoscopic surgeries, Contraindication to fluid intake 2 hours prior to surgery, Surgeries lasting for more than 3 hours, refusal to consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of hypothermia  Intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of postoperative shivering  Upto 2 hours postoperatively 
Temperature difference between the two groups  Intraoperatively 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
Final Enrollment numbers achieved (Total)= "116"
Final Enrollment numbers achieved (India)="116" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/10/2021 
Date of Study Completion (India) 15/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [neerja.bhardwaj@gmail.com].

  6. For how long will this data be available start date provided 01-10-2023 and end date provided 01-01-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Anaesthesia and surgery hamper the intrinsic mechanisms of thermoregulation, thus leading to unavoidable hypothermia. Maintenance of  normothermia is therefore of paramount importance. In patients undergoing elective caesarean section under neuraxial anaesthesia, oral carbohydrate loading has been shown to reduce incidence of shivering and is conducive to maintenance of normothermia. The proposed randomised controlled study will be conducted in ASA 1 and 2 children, 2-10 yrs old. Children would be randomly allocated to one of the two study groups using computer generated random number table –Oral carbohydrate (OC), Oral placebo (OP) group. The incidence of hypothermia, shivering and temperature difference between 2 groups will be noted. 
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