Dexmedetomidine Sedation in Children With Respiratory Morbidities

September 17, 2015 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

Feasibility of Dexmedetomidine in Children With Respiratory Morbidities Undergoing Deep Sedation for Magnetic Resonance Imaging

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Brussels, Vlaams Brabant, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events and they were eligible for participation in this evaluation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the occurrence of successful sedation
Time Frame: 1 hour
completion of imaging without requirement for rescheduling or general anaesthesia, and in the absence of adverse respiratory events such as apnoea, cough, oxygen desaturation, and bronchospasm or unplanned escalation of care (e.g. transfer from ward to paediatric intensive care unit or prolonged hospitalization).
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the presence of bradycardia
Time Frame: 4 hours
Based on age-adjusted criteria, bradycardia was defined as a HR <20% below the lower limit of the normal ranges expressed in beats/min
4 hours
the presence of hypertension
Time Frame: 4 hours
Based on age-adjusted criteria hypertension was defined as a MAP >20% above the upper limit of the normal ranges expressed in mmHg
4 hours
the presence of nausea and vomiting.
Time Frame: 4 hours
defined as the occurrence of nausea and vomitting, expressed in "yes" or "no"
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Nadia Najafi, MD, Universitair Ziekenhuis Brussel
  • Study Chair: Jan Poelaert, PhD MD, Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Estimate)

September 21, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEXMRI20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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