Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

NCT02299232 | Completed Phase 4

• 1 other identifier: 295/25.02.2014
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sixty patients aged between 1-10 years, American Society of Anesthesia (ASA) physical status I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1 received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From the beginning on every 10 minutes heart rate (HR), saturation (SpO2) and Ramsey Sedation Score (RSS) were recorded. Induction time was time interval to receive RSS 5. MRI began and separation-score was noted. If intranasal sedation failed, an intravenous canula was placed and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.

Conditions

Anesthesia

Keywords

dexmedetomidine; sedation; MRI

Outcome Measures

Primary Outcomes (1)

• Ramsey Sedation Score

  a score to determine sedation deepness

  every 10 minutes for a two hours period

Study Arms (2)

dexmedetomidine 3mcg/kg

ACTIVE COMPARATOR

dexmedetomidine 3 mcg/kg intranasal 50 minutes before MRI

Drug: Dexmedetomidine

dexmedetomidine 4mcg/kg

ACTIVE COMPARATOR

dexmedetomidine 4 mcg/kg intranasal 50 minutes before MRI

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Drug: dexmedetomidine 100 mcg/mL was applied in 3 mcg/kg and 4 mcg/kg doses in 1 mL preperates, 0.5 mL for each nostril

Also known as: precedex

dexmedetomidine 3mcg/kg; dexmedetomidine 4mcg/kg

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• MRI
• ASA I-II

You may not qualify if:

• hepatic and renal failure
• difficult airway
• nasal deformity
• anaphylaxis to dexmedetomidine
• neurologic disease
• metabolic disorders
• electrolyte imbalance
• dehydration
• malnutrition

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Related Publications (3)

• Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available.

  PMID: 23325950 BACKGROUND

• Gyanesh P, Haldar R, Srivastava D, Agrawal PM, Tiwari AK, Singh PK. Comparison between intranasal dexmedetomidine and intranasal ketamine as premedication for procedural sedation in children undergoing MRI: a double-blind, randomized, placebo-controlled trial. J Anesth. 2014 Feb;28(1):12-8. doi: 10.1007/s00540-013-1657-x. Epub 2013 Jun 26.

  PMID: 23800984 BACKGROUND

• Tug A, Hanci A, Turk HS, Aybey F, Isil CT, Sayin P, Oba S. Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging Sedation. Paediatr Drugs. 2015 Dec;17(6):479-85. doi: 10.1007/s40272-015-0145-1.

  PMID: 26323489 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hacer Sebnem Turk, MD

  Sisli Hamidiye Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 24, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 25, 2017

Record last verified: 2017-10