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
|
|
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
|
|
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. |