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CTRI Number  CTRI/2022/12/048145 [Registered on: 15/12/2022] Trial Registered Prospectively
Last Modified On: 12/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between opioid based with opioid free total intravenous anaesthesia in children undergoing lower abdominal surgeries 
Scientific Title of Study   Comparative evaluation of opioid based with opioid free total intravenous anaesthesia in children undergoing infraumbilical surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali 
Designation  Post graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room no- 302,BL Taneja block ,3rd floor, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  8054307370  
Fax    
Email  dr.anjali9191@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonia Wadhawan 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Room no 302 ,BL Taneja block ,3rd floor, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9810946845  
Fax    
Email  soniawadhawan@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Anjali 
Designation  Post graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room no 302 ,BL Taneja block ,3rd floor, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  8054307370  
Fax    
Email  dr.anjali9191@gmail.com  
 
Source of Monetary or Material Support  
Lok Nayak Hospital, JLN Marg,near Delhi Gate, New Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College and associated Lok Nayak Hospital 
Address  JLN Marg, New Delhi ,110002 
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 
Anjali  Lok Nayak Hospital  Department of Anesthesiology and Intensive Care, BL Taneja block, Maulana Azad Medical College, Lok Nayak Hospital, JLN Marg
New Delhi
DELHI 		 8054307370

dr.anjali9191@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Maulana Azad Medical College  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  Opioid based  Loading dose of fentanyl will be given at the rate of 1.5mcg/kg over 10 mins. Anesthesia will be induced with propofol using TCI(Target Controlled Infusion) pump to achieve Target plasma concentration of 2mcg/ml and will titrate the infusion to achieve BIS value 40-60. Maintenance of anesthesia will be done with fentanyl at the rate 0.5mcg/kg/hr and propofol infusion altered to keep BIS in between 40-60. Fentanyl will be stopped 10 minutes prior to the expected time of completion of surgery and propofol will be altered for timely awakening at the end of the surgery. 
Comparator Agent  Opioid free  Loading dose of dexmedetomidine will be given at the rate of 0.5mcg/kg over 10 mins. Anesthesia will be induced with propofol using TCI(Target Controlled Infusion) pump to achieve Target plasma concentration of 2mcg/ml and will titrate the infusion to achieve BIS value 40-60. Maintenance of anesthesia will be done with dexmedetomidine at the rate 0.3mcg/kg/hr and propofol infusion altered to keep BIS in between 40-60. Dexmedetomidine will be stopped 10 minutes prior to the expected time of completion of surgery and propofol will be altered for timely awakening at the end of the surgery 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children 4-8 years of age belonging to American Society of Anesthesiologists (ASA) grade I and II undergoing elective infraumblical surgery of duration upto two hours under total intravenous anaesthesia. 
 
ExclusionCriteria 
Details  1.Any known allergies to general anaesthetics.
2.Anticipated difficult airway. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Amount of propofol(mg/kg/hr) required for maintenance of anaesthesia in both the groups.  Intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Dose of propofol (mg/kg) required for induction of anaesthesia in both the groups.  Intraoperatively 
Hemodynamic response to I-Gel insertion.  Intraoperatively 
Intraoperative hemodynamic parameters ,respiratory rate and saturation  Intraoperatively 
Recovery time (to achieve Modified Aldrete score of 9 and more)  Intraoperatively 
Incidence of emergence delirium as assessed by Watcha scale  5 minutes of removal of supraglottic device 
Post operative pain assessed by FLACC score  10 minutes after recovery from anaesthesia 
Post operative complications ,if any  Post operative period 
 
Target Sample Size   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)   19/12/2022 
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   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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  dr.anjali9191@gmail.com

  6. For how long will this data be available start date provided 17-07-2024 and end date provided 17-07-2027?
    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   We are comparing total intravenous anaesthesia using Fentanyl-Propofol vs Dexmedetomidine-Propofol with regards to propofol consumption in paediatric patients undergoing infraumblical surgeries. Here we allocate the child to either group and than give the loading dose of fentanyl or dexmedetomidine for 10 minutes. After that propofol will be given via Target Controlled Infusion (TCI) pump to achieve target plasma concentration of 2mcg/ml and will titrate the infusion to achieve Bispectral Index (BIS) value between 40-60 followed by maintenance dose of fentanyl or dexmedetomidine. Our primary purpose of this study is to assess the propofol requirement at maintenance when anaesthesia is supplemented with fentanyl or dexmedetomidine in children by taking a total sample size of 100, 50 children in each group. 
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