Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

Phase 2

Completed

• Conditions: Postoperative Care; Intensive Care Unit
• Interventions: Drug: Dexmedetomidine Hydrochloride

• Registration Number: NCT04027829
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Study Start: 2019-08-14
• Primary Completion: 2019-11-14
• Study Completion: 2019-11-14
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine Hydrochloride	Intravenous infusion of dexmedetomidine for 50 min after surgery at intensive care unit

Primary Outcome Measures

Name	Time	Method
University of Michigan Sedation Scale	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)
Bispectral index	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)
Plasma concentration of dexmedetomidine	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

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	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
Incidence of arrhythmia	From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion	Presence of any kind of arrhythmia from electrocardiogram following dexmedetomidine infusion
Non-invasive blood pressure	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
Incidence of desaturation	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
Incidence of nausea	From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion	Incidence of nausea following dexmedetomidine infusion
Incidence of vomiting	From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion	Incidence of vomiting following dexmedetomidine infusion

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongro Gu, Korea, Republic of