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Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

NCT ID: NCT02299232

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia

Keywords

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dexmedetomidine sedation MRI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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dexmedetomidine 3mcg/kg

dexmedetomidine 3 mcg/kg intranasal 50 minutes before MRI

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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

dexmedetomidine 4mcg/kg

dexmedetomidine 4 mcg/kg intranasal 50 minutes before MRI

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

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precedex

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Canan Tulay ISIL

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hacer Sebnem Turk, MD

Role: PRINCIPAL_INVESTIGATOR

Sisli Hamidiye Etfal Training and Research Hospital

References

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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.

Reference Type BACKGROUND
PMID: 23325950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23800984 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26323489 (View on PubMed)

Other Identifiers

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295/25.02.2014

Identifier Type: -

Identifier Source: org_study_id