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CTRI Number  CTRI/2019/03/018082 [Registered on: 13/03/2019] Trial Registered Prospectively
Last Modified On: 05/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of steroid (dexamethasone) on the action of muscle relaxant (atracurium) in children undergoing surgery 
Scientific Title of Study   A double blind randomized controlled trial - Effect of intravenous dexamethasone on the onset time and recovery profiles of atracurium in children  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lokesh Kashyap 
Designation  Professor 
Affiliation  AIIMS 
Address  Department of Anaesthesia, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9868397821  
Fax    
Email  lokeshkashyap@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lokesh Kashyap 
Designation  Professor 
Affiliation  AIIMS 
Address  Department of Anaesthesia, AIIMS, New Delhi


DELHI
110029
India 
Phone  9868397821  
Fax    
Email  lokeshkashyap@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lokesh Kashyap 
Designation  Professor 
Affiliation  AIIMS 
Address  Department of Anaesthesia, AIIMS, New Delhi


DELHI
110029
India 
Phone  9868397821  
Fax    
Email  lokeshkashyap@yahoo.com  
 
Source of Monetary or Material Support  
All India Institue of Medical Sciences New Delhi 
 
Primary Sponsor  
Name  Department of Anaesthesiology AIIMS 
Address  All India institute of medical sciences New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Germany  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lokesh Kashyap  AIIMS, New Delhi  Room.5018,Department of Anaesthesiology, AIIMS, New Delhi
South
DELHI 
9868397821

lokeshkashyap@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Dexamethasone  A single injection of 0.15 mg/kg upto a maximum of 5mg of dexamethasone diluted to a total volume of 2ml with 0.9% saline will be given at the time of induction intravenously by the anaesthesia team present for the case. 
Comparator Agent  Placebo  A single injection of 2ml of 0.9% saline will be given intravenously at the time of induction by the anaesthesia team present for the case.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  ASA I and ASA II children undergoing surgery 
 
ExclusionCriteria 
Details  1. Patients who had taken a steroid medication within the last 24 h or had received chronic steroid medication or medicines, such as furosemide, magnesium, or cephalosporin, known to influence the neuromuscular function.
2. Patients with neuromuscular disease or hepatic and renal disease.
3. A history of allergy to atracurium and dexamethasone.
4. Severe and significant congenital heart disease.
5. Parental refusal.
6. Weight < 10 kilogram.
7. Suspected difficult airway.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
a) Onset time: the time in seconds between the start of atracurium injection and maximum T1 depression
b) The incidence of incomplete neuromuscular block (below 95% T1 depression).
 
time - 0
 
 
Secondary Outcome  
Outcome  TimePoints 
a) The time in minutes between the start of atracurium injection and 25% twitch height recovery of T1 (clinical duration).
b) The time in minutes between 25 and 75% twitch height recovery of T1 (recovery index).
c) The time in minutes between the 25% twitch height recovery of T1 and recovery of neuromuscular block to a TOF ratio of 0.9 (recovery time).
d) The time between the start of atracurium injection till the recovery of neuromuscular block to a TOF ratio of 0.9 (total recovery time).
 
Time - 0, 25, 75, 90 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/04/2019 
Date of Study Completion (India) 07/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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)?  

Brief Summary
Modification(s)  

Background and rationale :

             Dexamethasone is commonly used in the perioperative period for the prevention of postoperative nausea and vomiting (PONV), and for reducing the severity of postoperative pain and requirement of opioids. The frequent use of dexamethasone in the perioperative period albeit as a single dose as brought out the question of possible drug interactions with other anaesthetic agents.

             It has been shown previously that chronic steroid intake can reduce the duration of neuromuscular block. Moreover, methylprednisolone given intravenously pre or intraoperatively can reduce the duration of action of neuromuscular blockers. Few trials on phrenic nerve-diaphragm preparations in rats have also shown that dexamethasone can shorten the duration of action of neuromuscular blockers. More recently Young so et al showed that intravenous dexamethasone can also have the same effect on neuromuscular blockers. In both these trails clinically relevant change in the duration of action of neuromuscular blockers have only been seen when the dose was administered atleast 2 to 3 hours prior to induction. However, in clinical practice dexamethasone is commonly given only at induction. This could take clinical relevance if the duration of surgery extends beyond 2 or 3 hours.

              Moreover, both these trails were done only on adult population. Till date there have been no studies carried out in children to demonstrate the effect of intravenous dexamethasone on neuromuscular blocking agents. Hence it would be naïve to directly extrapolate the findings in adult population to children owing to the different physiological profile in them.             

   Thus, the present study aimed to demonstrate the effect of dexamethasone on the duration of action of atracurium in children undergoing elective surgery under general anesthesia. The Primary objective was to assess the impact on onset time and incidence of incomplete neuromuscular block. The secondary outcomes were clinical duration, recovery index, recovery time, and total recovery period.   

Results: The onset time and recovery index time were lower (1.96± 0.39, 8.04± 2.14 respectively) with dexamethasone in comparison to saline (2.01± 0.51, 8.9± 3.4 respectively) but not statistically significant. The clinical duration, recovery time, and total Recovery period were similar.No instances of incomplete neuromuscular block.

Conclusion: Application of a single bolus dose (0.15 mg/kg) of dexamethasone during induction does not attenuate atracurium-induced neuromuscular blockade in children.      

 
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