The Pharmacokinetics of Dexmedetomidine in Children

NCT00909935 | Terminated DMC

• 1 other identifier: 09-02-0067
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to identify the plasma concentrations which are required to achieve adequate sedation, using a Ramsay Sedation Scale. As an alpha 2 agonist, dexmedetomidine can elicit hemodynamic changes, fluctuations in blood pressure and heart rate. This study will attempt to determine whether these changes can be predicted by plasma concentrations.

Conditions

MRI Sedation

Keywords

To determine pharmacokinetics of dexmedetomidine in children

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of dexmedetomidine in pediatric patients

  2012-2015

Interventions

Dexmedetomidine DRUG

Initial 2 mcg/kg bolus administered over 10 minutes to achieve the Ramsey sedation score of 4 followed by an infusion of 1.5 mcg/kg/hr, which will run until patient is transferred to recovery area. Up to a further two boluses of 2 mcg/kg may be given to maintain an RSS of 4.

Also known as: Precedex

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children requiring sedation for MRI scanning

You may qualify if:

• Age 3 - 11.9 years
• age groups: 3.0 - 5.9 years, 6.0 - 11.9 years
• Patients will be equally distributed within each age group
• Meets criteria to receive dexmedetomidine sedation for MRI:
• Active, uncontrolled gastroesophageal reflux - an aspiration risk
• Active, uncontrolled vomiting - an aspiration risk
• Current (or within past 3 months) history of apnea requiring an apnea monitor
• Active, current respiratory issues that are different from the baseline status (pneumonia,exacerbation of asthma, bronchiolitis, respiratory syncytial virus)
• Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy,significant cardiac dysfunction)
• Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
• Current use of digoxin
• Moya Moya Disease
• New-onset stroke
• Provide written consent to take part in the research study

You may not qualify if:

• Do not meet established sedation criteria
• History of allergy, intolerance, or reaction to dexmedetomidine or hypersensitivity
• Previous diagnosis of hepatic insufficiency/failure or a serum glutamate pyruvate transaminase level \> 2 times the normal limit determined by Children's Hospital Boston (TCH)
• Current diagnosis of renal insufficiency/failure or a current serum creatinine level \> 1.5 times the normal limit determined by TCH
• Have received digoxin in the past (no time limit)
• Received phenobarbital, clonidine or valproic acid within 30 days
• Current, repaired or risk of Moya-Moya disease
• Recent stroke (cerebrovascular accident) within past 6 months
• Uncontrolled hypertension
• Concomitant use of beta antagonist, or calcium channel blocker
• Participated in a clinical investigation within the past three months

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Keira P. Mason, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate in Perioperative Anesthesia

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 29, 2009
• Study Start: April 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

US (1)