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Completed

NCT Number: NCT02299232

Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

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.

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Key information

Conditions

Anesthesia

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

OBJECTIVES OF STUDY Anesthetic agents used for MRI in paediatrics should have few adverse effects, allow fast induction and recovery. The administration route is also important and should be minimally invasive. In this study the investigators aimed to compare two different doses of intranasal dexmedetomidine applied to children for MRI sedation.

MATERIALS AND METHODS Sixty patients aged between 1-10 years, ASA 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 HR, SpO2 and 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MRI
  • ASA I-II

Exclusion criteria

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

Treatment and study plan

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

Other names: precedex

Primary outcomes

  1. Ramsey Sedation Score

    Time frame: every 10 minutes for a two hours period

    a score to determine sedation deepness

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

Acronym: DEX

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2014
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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