To evaluate the effect of dexmedetomidine premedication on sedation in children undergoing MRI Brain

Efficacy of Dexmedetomidine as an adjuvant to Propofol based total intravenous anaesthesia (TIVA) among children undergoing MRI : A single blinded randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028399

Enrollment

150

Registered

2020-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: F71- Moderate intellectual disabilities

Interventions

Intervention1: Bolus dose of dexmedetomidine: Single intravenous bolus dexmedetomidine dose (0.5 mcg/kg) over 2-3 minutes and followed by intravenous propofol bolus dose (1 mg/kg) and then a by mainte

Eligibility

Inclusion criteria

Inclusion criteria: All ASA I, II children under the age of 1-15 years who are posted for MRI Brain

Exclusion criteria

Exclusion criteria: 1. Difficult IV access requiring sevoflurane for more than 5 minutes 2. Pre induction haemodynamic instability (bradycardia, tachycardia, hypotension)or respiratory vital / danger signs ( Active respiratory infection, airway obstruction, tachypnea, mild wheeze) 3. Children taking more than two antiepileptic drugs 4. Known allergy to study drugs

Design outcomes

Primary

Measure	Time frame
To compare Recovery time of two techniques by using Ramsay sedation scale scoreTimepoint: To compare Recovery time of two techniques - Time from discontinuation of study drugs till Ramsay sedation scale score 2	—

Secondary

Measure	Time frame
To compare time to induction, number of interruption of scan sequences, total dose of propofol administered and adverse event profile among two groups.Timepoint: Interruption of scan sequences - Visualized gross movements as noted from MRI console or motor artefact interrupting scan sequences Time to induction ? Time from starting IV induction with study drugs till Ramasay sedation Scale score of 5 or 6 Total dose of propofol administered Adverse event profile -Apnea, airway obstruction,Moderate and mild hemoglobin oxygen desaturation, bradycardia and tachycardia Vitals will be monitored at baseline and then every 5 minutes till discharge	—

Measure

Time frame

To compare time to induction, number of interruption of scan sequences, total dose of propofol administered and adverse event profile among two groups.Timepoint: Interruption of scan sequences - Visualized gross movements as noted from MRI console or motor artefact interrupting scan sequences Time to induction ? Time from starting IV induction with study drugs till Ramasay sedation Scale score of 5 or 6 Total dose of propofol administered Adverse event profile -Apnea, airway obstruction,Moderate and mild hemoglobin oxygen desaturation, bradycardia and tachycardia Vitals will be monitored at baseline and then every 5 minutes till discharge

—

Countries

India

Contacts

Public ContactKishorkumar

Christian Medical College, Vellore

drektarai@yahoo.com9789250113

Outcome results

None listed

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