Dexmedetomidine Sedation in Children With Respiratory Morbidities

NCT ID: NCT02555605

Last Updated: 2015-09-21

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

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-07-31

Brief Summary

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This study aimed to determine the feasibility of dexmedetomidine in children with respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.

Detailed Description

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Electronic medical records of children with at least 3 characteristics of respiratory morbidities were retrospectively reviewed. All study patients received dexmedetomidine bolus over 10 min followed by a continuous infusion to achieve a minimum Ramsay Sedation Score of 5. Patients were monitored for hemodynamics, total dose of dexmedetomidine received, adverse events experienced and sedation characteristics.

Conditions

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Respiratory Morbidity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Dexmedetomidine

Children up to the age of 16 years requiring MRI under deep sedation with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events. Dexmedetomidine was administered as a first bolus of 1 mcg•kg-1 over 10 min, followed by a continuous infusion at 1.0 mcg•kg-1•h-1. Sedation level was assessed by Ramsay Sedation Scale and it was initially recorded at 1-min interval. If the child failed to achieve a minimum RSS of 5, this bolus was repeated once again and the continuous infusion was subsequently increased to 2 mcg•kg-1•h-1. In addition, propofol 0.5 mg.kg-1 iv. was allowed to be administered, in patients still exhibiting movement that could interfere with image acquisition.

Intervention Type DRUG

Other Intervention Names

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Dexdor

Eligibility Criteria

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Inclusion Criteria

* Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities

Exclusion Criteria

* Children who had an American Society of Anaesthesiologists (ASA) physical status classification IV
* Documented pre-existing cardiac conduction abnormalities
* Renal impairment
Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Veerle Van Mossevelde

Data Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadia Najafi, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Jan Poelaert, PhD MD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Brussels, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

References

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Najafi N, Veyckemans F, Van de Velde A, Poelaert J. Usability of dexmedetomidine for deep sedation in infants and small children with respiratory morbidities. Acta Anaesthesiol Scand. 2016 Aug;60(7):865-73. doi: 10.1111/aas.12715. Epub 2016 Mar 4.

Reference Type DERIVED
PMID: 26940080 (View on PubMed)

Other Identifiers

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DEXMRI20

Identifier Type: -

Identifier Source: org_study_id

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