Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

Seoul National University Hospital13 enrolled

Overview

This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for 50 minutes after surgery as as sedation drug.

Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural sedation or sedation at intensive care unit. However, the safety and efficacy profile are not yet established for children. Although there have been some studies regrading it, still there is no public guideline, therefore making it difficult to use dexmedetomidine in children.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Intensive Care Unit Postoperative Care

Interventions

Dexmedetomidine HydrochlorideDRUG

Intravenous infusion of dexmedetomidine at the rate of 0.5mcg/kg for 10 min, then 0.5mcg/kg/hr for 50 min.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pediatric patients planned to undergo mechanical ventilation at intensive care unit after surgery * Pediatric patients planned to be extubated within 4 hours after surgery for neurological examination * Patients whose parent of legal guardian agreed to enroll in the study after having enough time to review the complete explanation about the study. Exclusion Criteria: * History of hypersensitivity to any drugs including dexmedetomidine. * Underlying cardiovascular/circulatory disease * Underlying liver / kidney disease * Patients under hemodialysis * Obesity of BMI \> 35 * Patients planned to receive patient-controlled analgesia including opioids * Patients whose parent or legal guardian declined to enroll in the study * Other conditions deemed unsuitable for the study

Locations (1)

Seoul National University Hospital

Seoul, Jongro Gu, South Korea

Outcomes

Primary Outcomes

Plasma concentration of dexmedetomidine

Plasma concentration of dexmedetomidine before infusion, 10/30/60 minutes after initiation of infusion, 15/30/60/120/240/480 minutes after end of infusion

Time frame: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion

Bispectral index

Bispectral index based on electroencephalogram during patient's stay at intensive care unit (0-100, lower score implies deeper sedation)

Time frame: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion

University of Michigan Sedation Scale

University of Michigan Sedation Scale based on observer's inspection during patient's stay at intensive care unit (0-4, higher score implies deeper sedation)

Time frame: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion

Secondary Outcomes

Incidence of arrhythmia

Presence of any kind of arrhythmia from electrocardiogram following dexmedetomidine infusion

Time frame: From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion

Non-invasive blood pressure

Non-invasive blood pressure in units of mmHg, to examine whether hypertension (increase in blood pressure more than 20% of baseline) or hypotension (decrease in blood pressure more than 20% of baseline) occurs

Time frame: From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion

Incidence of desaturation

Presence of desaturation (pulse oximetry of lower than 94%) following dexmedetomidine infusion

Data from ClinicalTrials.gov

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