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NCT Number: NCT04027829

Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

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.

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Key information

Conditions

Intensive Care Unit Postoperative Care

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, Jongro Gu, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Hydrochloride

Drug

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

Other names: Precedex

Primary outcomes

  1. Plasma concentration of dexmedetomidine

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

    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

  2. Bispectral index

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

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

  3. University of Michigan Sedation Scale

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

    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)

Secondary outcomes

  1. Incidence of arrhythmia

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

    Presence of any kind of arrhythmia from electrocardiogram following dexmedetomidine infusion

  2. Non-invasive blood pressure

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

    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

  3. Incidence of desaturation

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

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

  4. Respiratory rate

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

    Respiratory rate in units of /min, to examine whether respiratory depression or apnea occurs

  5. Incidence of nausea

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

    Incidence of nausea following dexmedetomidine infusion

  6. Incidence of vomiting

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

    Incidence of vomiting following dexmedetomidine infusion

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Food and Drug Safety, Korea

Registry information

Official study title

Pharmacokinetic-pharmacodynamic Analysis for Dosing Strategy and Evaluation of Safety and Efficacy of Dexmedetomidine in Children

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2019
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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