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CTRI Number  CTRI/2024/03/064283 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 09/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of three anaesthesia medicines for insertion of a device into the breathing pipe in children using a brain function monitor  
Scientific Title of Study   Comparison of bispectral index guided propofol, etomidate and etofol infusion for supraglottic airway device insertion in paediatric patients: a randomised controlled trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitin Choudhary 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 5104, Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Anasari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  8447698566  
Fax    
Email  drnitinchoudhary@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Shreya Shah 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 5104, Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Anasari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Shreya Shah 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 5104, Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Anasari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi 
Address  5th floor, Academic block, AIIMS, Ansari Nagar, New Delhi 110029 
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 
Dr Shreya Shah  All India Institute of Medical Sciences  5 th floor, Academic Block, AIIMS, Ansari Nagar, New Delhi 110029
New Delhi
DELHI 
9892652781

shreyabs@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z40-Z53||Encounters for other specific health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Etomidate arm  Etomidate (2mg/ml) at an infusion rate of 200ml/hour 
Comparator Agent  Propofol arm  Propofol (10mg/ml) infusion at rate of 200ml/hour 
Intervention  Propofol-etomidate arm  1:1 combination of the propofol (10mg/ml) and etomidate (2mg/ml) at an infusion rate of 200ml/hour 
 
Inclusion Criteria
Modification(s)  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Patients scheduled to undergo surgery under general anaesthesia
2. Age 6 to 10 years
3. American Society of Anesthesiologists (ASA) physical status I/II
 
 
ExclusionCriteria 
Details  1. Patients with anticipated difficult airway
2. Known allergy to study drugs
3. History of seizure disorder
4. Any contraindications to the placement of supraglottic airway device
5. Refusal to participate
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1. To compare the change in the mean arterial pressure with propofol, etomidate and etofol to achieve BIS value of 50 for SAD insertion in paediatric patients aged 6 to 10 years.  Baseline, At BIS 50, After supraglottic airway placement,1 minute after placement, 2 minutes after placement, 5 minutes after placement 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time taken to achieve BIS value of 50
2. Change in heart rate between the study groups
3. Other side effects of intravenous study drugs (such as myoclonus, pain on injection etc)
4. SAD related parameters (insertion summed score, number of attempts taken, time taken for insertion, additional study drug boluses required)
 
Baseline, At BIS 50, After supraglottic airway placement,1 minute after placement, 2 minutes after placement, 5 minutes after placement 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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 3 
Date of First Enrollment (India)   30/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

           Propofol is the most common inducing agent for general anaesthesia. Propofol obtunds the airway reflexes and provides good conditions for airway management. However though titrated to effect, propofol causes hypotension and a decreased heart rate on induction. This hypotension and bradycardia may be pronounced in paediatric population, with a parasympathetic predominance. Etomidate, another inducing agent is known to provide a better haemodynamic stability compared to propofol. However, both propofol and etomidate cause pain on injection and myoclonus. 

           The aim of our study is to compare the haemodynamic stability between induction doses of propofol, etomidate and propofol-etomidate combination (titrated using bispectral index monitoring) in paediatric patients. We aim to see which drug provides the best conditions for insertion of supraglottic airway device (SAD)  with least side-effects. The primary objective of our study is to compare the change in the mean arterial pressure with propofol, etomidate and etofol to achieve BIS value of 50 for SAD insertion in paediatric patients aged 6 to 10 years. Our secondary objectives are 1. To determine the time taken to achieve BIS value of 50 2. Change in heart rate between the study groups 3. Other side effects of intravenous study drugs (such as myoclonus, pain on injection etc. 4. SAD related parameters (insertion summed score, number of attempts taken, time taken for insertion, additional study drug boluses required). 

           Institute ethics committee approval was sought for. A written informed consent/assent will be obtained from all patients. We conducted a pilot study to calculate the sample size.  Assuming the power as 90% at alpha error of 5 %, 44 patients will be recruited in each group. One hundred and thirty two patients with ASA physical status I/II scheduled for surgery under general anaesthesia aged between 6 to 10 years will be included in our study. The exclusion criteria are 1. Patients with anticipated difficult airway 2. Known allergy to study drugs 3. History of seizure disorder 4. Contraindications to the placement of SAD 5. Refusal to participate. 

           Patients will be randomly allocated into 3 groups based on computer generated random number table with group allocation using sealed opaque envelopes- Group P (Propofol), group E (Etomidate) and group EP (etofol i.e. etomidate and propofol). The patients and investigator will be blinded to the study groups. On the day of surgery, patients will be premedicated with midazolam in a dose of 20mcg/kg IV. In the operating room, after attaching standard ASA monitors and bispectral (BIS) index electrode, baseline vital parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure and oxygen saturation on room air) will be recorded. All patients will receive fentanyl @ 1mcg/kg IV. The study drugs will be prepared in a 20ml syringe while will be injected using a infusion pump. Patient in group P and E will receive propofol (10mg/ml) and etomidate (2mg/ml) while the patient in group PE will receive the 1:1 combination of the propofol (10mg/ml) and etomidate (2mg/ml) at an infusion rate of 50 ml/hour. The infusion will continue will till BIS value of 50 is achieved thereafter the infusion will be stopped. Once a BIS value of 50 is attained, SAD of adequate size as per the weight of the patient will be inserted. 

          The haemodynamic parameters will be monitored at following time points namely the baseline parameters, after the induction of anaesthesia when BIS reaches 50,during placement of SAD, 1, 2 and 5 minutes after placement of SAD. A difference of more than 20% from the baseline will be considered significant. The other parameters observed will include: time to attain BIS of 50, pain during injection of study drugs using four-graded scale, Myoclonus severity (0-3), total number of attempts and time taken to successfully place SAD, insertion conditions terms of mouth opening, coughing, swallowing, movements, laryngospasm and ease of SAD insertion.

 

 
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