Comparision of Dexmeditomedine and Midazolam for MRI sedation in newborn babies

To compare the efficacy of intravenous Dexmedetomidine with intravenous midazolam for sedation during MRI in neonates - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069328

Enrollment

Registered

2024-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Inj. Dexmedetomidine: Given as a single dose of 0.5 micrograms/kg as slow iv over 10 minutes Control Intervention1: Inj. Midazolam: Given as a single dose of 0.1 milligram/kg as slow

Eligibility

Inclusion criteria

Inclusion criteria: All neonates who fulfill the following criteria: 1. Late preterm (34 completed weeks and above) and term neonates requiring MRI brain. 2.Neonates failing oral sedation with one dose of Trichlofos

Exclusion criteria

Exclusion criteria: Neonates with major congenital anomalies

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of intravenous Dexmedetomidine with intravenous midazolam for neonates who failed oral sedation for MRI brain.Timepoint: completion of MRI within 1 hour of sedation	—

Secondary

Measure	Time frame
1.Need for an additional sedation for completion of MRI brain. 2.Duration of sedation post procedure in hours. 3.Adverse effects following the medication (Inj midazolam – irritability, apnoea, bronchospasm, myoclonic seizures, tachypnea Inj Dexmedetomidine -hypotension, bradycardia, hypoventilation, hypercapnia) Timepoint: 6 hours after giving the intervention or comparitive drug	—

Countries

India

Contacts

Public ContactDr Srushty Suresh

JSS Medical College

drdsrinivasa@gmail.com9980941161

Outcome results

None listed

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