| CTRI Number |
CTRI/2024/02/062935 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Sedation level assessment after bolus dose of Dexmedetomidine in children with Developmental Delay |
|
Scientific Title of Study
|
Patient state index changes following a bolus dose of dexmedetomidine
in children with global developmental delay. |
| 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 Radhakrishnan M |
| Designation |
Professor |
| Affiliation |
National institute of Mental Health and Neurosciences |
| Address |
3rd floor, faculty building, department of Neuroanesthesia, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9632589296 |
| Fax |
|
| Email |
mrks1974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhakrishnan M |
| Designation |
Professor |
| Affiliation |
National institute of Mental Health and Neurosciences |
| Address |
Department of Neuroanesthesia, NIMHANS,Hosur road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9632589296 |
| Fax |
|
| Email |
mrks1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhakrishnan M |
| Designation |
Professor |
| Affiliation |
National institute of Mental Health and Neurosciences |
| Address |
Department of Neuroanesthesia, NIMHANS,Hosur road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9632589296 |
| Fax |
|
| Email |
mrks1974@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Mental Health and Neurosciences , Begaluru |
|
|
Primary Sponsor
|
| Name |
Dr Radhakrishnan M |
| Address |
Department of Neuroanesthesia, NIMHANS,Hosur road, Bengaluru |
| 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 Radhakrishnan M |
National institute of Mental Health and Neurosciences, Bengaluru |
Department of neuroanesthesia and neurocritical care, Hosur road, Bengaluru
Bangalore
KARNATAKA |
9632589296
mrks1974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee BS and NS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F849||Pervasive developmental disorder,unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 1-16 years posted for MRI (brain with infratentorial pathology, spine, GDD) under sedation
2. ASA physical status I-II |
|
| ExclusionCriteria |
| Details |
1. Children with pathology in the supratentorial intracranial compartment
2. ASA physical status III and above
3. Patients requiring sedatives other than Dexmedetomidine in the initial 10min bolus
dose administration
4. Children with endotracheal tube in situ or requires intubation during the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient state index |
baseline,after 10min bolus dose of Dexmeditomidine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RSA with PSI value between GDD and non-GDD |
every 5min |
| PSI and RSA at discharge between GDD and non-GDD |
discharge |
| movement episodes and rescue drug |
every 5min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Global developmental delay (GDD) is a relatively common neurodevelopmental disorder. These children, when subjected to magnetic resonance imaging (MRI) studies, require sedation and analgesia to achieve immobility and obtain clear images. For children requiring sedation for MRI study, it is our practice to administer a bolus dose of dexmedetomidine over 10 minutes followed by a continuous infusion with additional doses of midazolam, propofol or ketamine as rescue drugs, to keep the child sedated. The changes in PSI during dexmedetomidine administration in children with GDD is not studied earlier. The need for rescue medications to complete the study might differ between children with and without GDD. In this study, the investigators plan to study the changes in PSI as a measure of sedation in children following a bolus dose of dexmedetomidine and compare it with children not having GDD. This is a prospective study to evaluate patient state index changes following a bolus dose of dexmedetomidine in children with global developmental delay. |