Dexmedetomidine Sedation in Children With Respiratory Morbidities

Respiratory Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555605
• Other study ID #: DEXMRI20
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: September 17, 2015
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 16 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Respiratory Morbidity

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the occurrence of successful sedation	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	Yes
Secondary	the presence of bradycardia	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	Yes
Secondary	the presence of hypertension	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	Yes
Secondary	the presence of nausea and vomiting.	defined as the occurrence of nausea and vomitting, expressed in "yes" or "no"	4 hours	Yes