| CTRI Number |
CTRI/2018/07/014845 [Registered on: 13/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the three different protocols of sedation in Children undergoing Magnetic Resonance Imaging(MRI). |
|
Scientific Title of Study
|
Effectiveness of three regimens of sedation in children for Magnetic Resonance Imaging. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shwethashri |
| Designation |
Senior Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
£14, "VENKATESHA, ground floor, 3rd cross, Byrasandra extension, Jayanagar 1st block east. Bengaluru
3rd Floor, Neurofaculty block, Department of Neuroanaesthesiology and Neurocritical Care. National Institute of Mental Health and Neurosciences, Bengaluru- 560029
Bangalore
KARNATAKA
560011
India |
| Phone |
9916964747 |
| Fax |
|
| Email |
shwethashri.84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shwethashri |
| Designation |
Senior Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
£14, "VENKATESHA, ground floor, 3rd cross, Byrasandra extension, Jayanagar 1st block east. Bengaluru
3rd Floor, Neurofaculty block, Department of Neuroanaesthesiology and Neurocritical Care. National Institute of Mental Health and Neurosciences, Bengaluru- 560029
Bangalore
KARNATAKA
560011
India |
| Phone |
9916964747 |
| Fax |
|
| Email |
shwethashri.84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shwethashri |
| Designation |
Senior Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
£14, "VENKATESHA, ground floor, 3rd cross, Byrasandra extension, Jayanagar 1st block east. Bengaluru
3rd Floor, Neurofaculty block, Department of Neuroanaesthesiology and Neurocritical Care. National Institute of Mental Health and Neurosciences, Bengaluru- 560029
Bangalore
KARNATAKA
560011
India |
| Phone |
9916964747 |
| Fax |
|
| Email |
shwethashri.84@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore 560029 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shwethashri Ramaprasannakumar Kondavagilu |
National Institute of Mental Health and Neurosciences |
Department of Neuroanaesthesia and Neurocritical Care, 3rd Floor, Neurosciences Faculty Block, NIMHANS hHospital Complex, Hosur Road, Bangalore 560072
Bangalore
KARNATAKA |
9916964747
shwethashri.84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
• American Society of Anesthesiologists Physical status (ASAPs) 1 and 2
• MRI duration of 30 - 45 minutes |
|
| ExclusionCriteria |
| Details |
• Presence of anatomic airway abnormalities
• Presence of congenital heart diseases
• History of upper/lower respiratory treatment in the recent past
• History of allergy to the drugs used.
• Parents/ patient attenders refusal for the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of three regimens of sedation for MRI in children.
Propofol as a stand alone drug
Dexmedetomidine as a stand alone drug
Propofol and dexmedetomidine combination |
Baseline values before starting the study drug infusions and continued every 5 minutes during MRI till complete recovery from sedation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the following characteristics between three regimens.
Hemodynamic parameters
Respiratory parameters
Recovery characteristics
Adverse effects
|
At baseline before starting the study drug infusions and continued every 5 minutes during MRI till complete recovery from sedation. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2017 |
| Date of Study Completion (India) |
15/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
At MR induction room the children were
randomly allocated to one of the three groups as per the order obtained from a
computer generated table of random numbers. Patients in each group were
stipulated to any of the 3 groups as per the following protocol. Group- P (n-50) - received
propofol (1%) initially at 2-2.5mg/kg over 10minutes followed by infusion of
propofol 100 μg/kg/min until the completion of MRI. Group D (n-50) - received
dexmedetomidine initially at 2μg/kg bolus over 10 minutes followed by dexmedetomidine
infusion at 1 μg/kg/hour until the completion of MR imaging. Group PD (n- 50) - received propofol 2
-2.5mg/kg over 10 minutes followed by dexmedetomidine infusion at1μg/kg/hour
until the completion of MRI.
Monitoring during this time period
includes SPO2, ETCO2, NIBP, HR and RR that was continued
throughout the study time at each 5minutes interval. Sedation levels were
evaluated from the Modified Ramsay sedation score (MRSS) at every 5-minute
time intervals. MR Imaging was started once the sedation level of 4 was reached
as assessed from the MRSS. Outcome variables assessed at defined time points.
Children were observed till complete recovery from sedation and the
recovery characteristics noted.
|