To compare the three different protocols of sedation in Children undergoing Magnetic Resonance Imaging(MRI).

Completed

• Registration Number: CTRI/2018/07/014845
• Lead Sponsor: National Institute of Mental Health and Neurosciences

Brief Summary

- At MR induction room the children wererandomly allocated to one of the three groups as per the order obtained from acomputer generated table of random numbers. Patients in each group werestipulated to any of the 3 groups as per the following protocol.

Group- P (n-50)   - receivedpropofol (1%) initially at 2-2.5mg/kg over 10minutes followed by infusion ofpropofol 100 μg/kg/min until the completion of MRI.

Group D (n-50)  - receiveddexmedetomidine initially at 2μg/kg bolus over 10 minutes followed by dexmedetomidineinfusion 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/houruntil the completion of MRI.

Monitoring during this time periodincludes SPO2, ETCO2, NIBP, HR and RR that was continuedthroughout the study time at each 5minutes interval. Sedation levels wereevaluated from the Modified Ramsay sedation score (MRSS) at every 5-minutetime intervals. MR Imaging was started once the sedation level of 4 was reachedas assessed from the MRSS. Outcome variables assessed at defined time points.Children were observed till complete recovery from sedation and therecovery characteristics noted.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-26
• Study Completion: 2017-11-15
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• •American Society of Anesthesiologists Physical status (ASAPs) 1 and 2 •MRI duration of 30.
• 45 minutes.

Exclusion Criteria

• •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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Propofol as a stand alone drug	Baseline values before starting the study drug infusions and continued every 5 minutes during MRI till complete recovery from sedation.
To compare the effectiveness of three regimens of sedation for MRI in children.	Baseline values before starting the study drug infusions and continued every 5 minutes during MRI till complete recovery from sedation.
Dexmedetomidine as a stand alone drug	Baseline values before starting the study drug infusions and continued every 5 minutes during MRI till complete recovery from sedation.
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 Measures

Name	Time	Method
To compare the following characteristics between three regimens.	Hemodynamic parameters

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Mental Health and Neurosciences

🇮🇳Bangalore, KARNATAKA, India

Shwethashri Ramaprasannakumar Kondavagilu

Principal investigator

9916964747

shwethashri.84@gmail.com