CTRI Number |
CTRI/2020/01/022949 [Registered on: 27/01/2020] Trial Registered Prospectively |
Last Modified On: |
01/10/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of three different drug regimens for sedation in children undergoing MRI
|
Scientific Title of Study
|
Comparison of three different drug regimens for sedation in children undergoing Magnetic resonance imaging: A prospective randomized study
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rohit |
Designation |
Senior resident |
Affiliation |
Maulana azad medical college and Lok Nayak Hospital |
Address |
Maulana azad medical college, Lok nayak hospital, New Delhi 110002
Central DELHI 110002 India |
Phone |
09873520215 |
Fax |
- |
Email |
dr.rohitbalyan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Kirti Nath Saxena |
Designation |
HOD, Director Professor |
Affiliation |
Maulana azad medical college and Lok Nayak Hospital |
Address |
Maulana azad medical college, Lok nayak hospital, New Delhi 110002
Central DELHI 110002 India |
Phone |
9968604215 |
Fax |
- |
Email |
kirtinath@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Rohit |
Designation |
Senior resident |
Affiliation |
Maulana azad medical college and Lok Nayak Hospital |
Address |
Maulana azad medical college, Lok nayak hospital, New Delhi 110002
Central DELHI 110002 India |
Phone |
09873520215 |
Fax |
- |
Email |
dr.rohitbalyan@gmail.com |
|
Source of Monetary or Material Support
|
Maulana azad medical college and lok nayak hospital |
|
Primary Sponsor
|
Name |
Dr Rohit |
Address |
Department of Anaesthesia, lok nayak hospital |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Rohit |
Lok nayak hospital |
third floor, BL Taneja block, department of anaesthesia,lok nayak Bahadur shah zafar marg Central DELHI |
09873520215
dr.rohitbalyan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IECapproval_LokNayakhospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B||Imaging, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
dexmedetomidine
|
dose: 1mcg/kg I.V
route: intravenous
frequency: during mri procedure
duration: during mri procedure
|
Comparator Agent |
Ketamine |
dose: 1mg/kg
route: Intravenous
frequency: during MRI procedure
duration: dirung mri procedure
|
Comparator Agent |
Propofol |
dose: 1mg/kg
route of administration: Intravenous,
frequency: as infusion during the MRI procedure.
duration of therapy: during the mri procedure only. |
|
Inclusion Criteria
|
Age From |
1.00 Year(s) |
Age To |
10.00 Year(s) |
Gender |
Both |
Details |
American Society of Anaesthesiologists (ASA) status 1 and 2,
Aged 1 to 10 years,
Scheduled for elective MRI.
|
|
ExclusionCriteria |
Details |
Significant cardiovascular or pulmonary pathology,
Patients with any allergy or contraindication to study drugs,
Anatomical anomaly or suspected difficulty of the airway.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Time to discharge from recovery room. |
at baseline, after completion of imaging procedure. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time to Induction of sleep
|
time to achieve RSS of 4-5 after the loading dose |
Recovery/Awakening time |
Time to recovery from sedation to RSS 2 after stopping the drug infusion |
Quality of Induction, Quality of sedation, quality of MRI
|
during the scan |
Scan duration.
|
total time taken to complete MRI |
Incidence of emergence delirium based on the pediatric anesthesia emergence delirium (PAED) scale |
during recovery from sedation |
Parental satisfaction score about Anaesthesia and recovery.
|
during scan and recovery |
Incidence of adverse events namely postoperative nausea and vomiting (PONV), hemodynamics, respiratory events.
|
during scan and recovery |
|
Target Sample Size
|
Total Sample Size="51" Sample Size from India="51"
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)
|
30/01/2020 |
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 Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Magnetic resonance imaging (MRI) is a widely used radiology technique with its unique noisy environment and a narrow pipe like appearance. However, it is very difficult for a child to remain motionless to avoid movement artefact, and get a qualified image. General anaesthesia or sedation is frequently required to eliminate motion artefacts and to attenuate anxiety during MRI in young children or in children with complex medical conditions. Propofol(PRO) and dexmedetomidine(DEX) are commonly used for maintaining anaesthesia and sedation, and both are safe and effective in children undergoing MRI with few component scan (e.g., brain) and of short duration (<1 h). Compared with pentobarbital, midazolam, and fentanyl techniques, propofol yields faster induction, shorter emergence, less duration in postanaesthesia care unit (PACU), and fewer interruptions during the MRI related to patient movement. However, arterial desaturation, hypotension and dose-dependent response of upper airway collapse (by inhibition of airway dilator muscle and of upper airway reflexes) occasionally occur with the propofol technique. In order to minimize these side effects, some authors recommend the combination with other drugs like midazolam, opioids, ketamine or dexmedetomidine. The increasing popularity of dexmedetomidine use in children stems from its ability to provide adequate procedural sedation with a relatively low risk of respiratory depression. In addition, dexmedetomidine is associated with a significantly lower need for artificial airway support during sedation for magnetic resonance imaging (MRI) in children with obstructive sleep apnea, compared to propofol. Concomitant addition of two drugs can bring drug synergy effect on sedation and contributes to decreased risk of adverse effects. Therefore, by using combination regimen, it could provide short induction time, fast recovery, stable cardiorespiratory conditions, and rarely requires additional sedation, and therefore is safe and adequate for pediatric MRI sedation. The goal of our study is to compare propofol (with and without ketamine) and dexmedetomidine based sedation regimens for pediatric MRI sedation with respect to several measures such as timeliness, safety profile, image and sedation quality outcomes, and parental satisfaction in children undergoing multicomponent MRI scan. |