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Sedation level assessment after bolus dose of Dexmedetomidine in children with Developmental Delay

Patient state index changes following a bolus dose of dexmedetomidine in children with global developmental delay. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/02/062935
Enrollment
60
Registered
2024-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F849- Pervasive developmental disorder,unspecified

Interventions

Intervention1: Patient state index monitor: patient state index monitor at baseline and post MRI

Sponsors

Dr Radhakrishnan M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 1-16 years posted for MRI (brain with infratentorial pathology, spine, GDD) under sedation 2. ASA physical status I-II

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Patient state indexTimepoint: baseline,after 10min bolus dose of Dexmeditomidine—

Secondary

MeasureTime frame
movement episodes and rescue drugTimepoint: every 5min;PSI and RSA at discharge between GDD and non-GDDTimepoint: discharge;RSA with PSI value between GDD and non-GDDTimepoint: every 5min—

Countries

India

Contacts

Public ContactDr Radhakrishnan M

National institute of Mental Health and Neurosciences

mrks1974@gmail.com9632589296

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026