Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

NCT04027829 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 1905-188-1037
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit; Postoperative Care

Keywords

dexmedetomidine; pediatric; sedation

Outcome Measures

Primary Outcomes (3)

• 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

  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)

  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)

  From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion

Secondary Outcomes (6)

• Incidence of arrhythmia

  From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion

• Non-invasive blood pressure

  From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion

• Incidence of desaturation

  From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion

• Respiratory rate

  From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion

• Incidence of nausea

  From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

Intravenous infusion of dexmedetomidine for 50 min after surgery at intensive care unit

Drug: Dexmedetomidine Hydrochloride

Interventions

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.

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongro Gu, 03080, South Korea

Location

Related Publications (15)

• Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric anesthesiology. Pediatr Crit Care Med. 2007 Mar;8(2):115-31. doi: 10.1097/01.PCC.0000257100.31779.41.

  PMID: 17273114 BACKGROUND

• Su F, Hammer GB. Dexmedetomidine: pediatric pharmacology, clinical uses and safety. Expert Opin Drug Saf. 2011 Jan;10(1):55-66. doi: 10.1517/14740338.2010.512609. Epub 2010 Aug 18.

  PMID: 20718689 BACKGROUND

• Reiter PD, Pietras M, Dobyns EL. Prolonged dexmedetomidine infusions in critically ill infants and children. Indian Pediatr. 2009 Sep;46(9):767-73. Epub 2009 Apr 1.

  PMID: 19430081 BACKGROUND

• Banasch HL, Dersch-Mills DA, Boulter LL, Gilfoyle E. Dexmedetomidine Use in a Pediatric Intensive Care Unit: A Retrospective Cohort Study. Ann Pharmacother. 2018 Feb;52(2):133-139. doi: 10.1177/1060028017734560. Epub 2017 Sep 27.

  PMID: 28952341 BACKGROUND

• Sulton C, McCracken C, Simon HK, Hebbar K, Reynolds J, Cravero J, Mallory M, Kamat P. Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. 2016 Sep;6(9):536-44. doi: 10.1542/hpeds.2015-0280. Epub 2016 Aug 11.

  PMID: 27516413 BACKGROUND

• Plambech MZ, Afshari A. Dexmedetomidine in the pediatric population: a review. Minerva Anestesiol. 2015 Mar;81(3):320-32. Epub 2014 May 14.

  PMID: 24824958 BACKGROUND

• Kim HS, Byon HJ, Kim JE, Park YH, Lee JH, Kim JT. Appropriate dose of dexmedetomidine for the prevention of emergence agitation after desflurane anesthesia for tonsillectomy or adenoidectomy in children: up and down sequential allocation. BMC Anesthesiol. 2015 May 27;15:79. doi: 10.1186/s12871-015-0059-z.

  PMID: 26012345 BACKGROUND

• Mahmoud M, Mason KP. Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations. Br J Anaesth. 2015 Aug;115(2):171-82. doi: 10.1093/bja/aev226.

  PMID: 26170346 BACKGROUND

• Tobias JD, Berkenbosch JW. Sedation during mechanical ventilation in infants and children: dexmedetomidine versus midazolam. South Med J. 2004 May;97(5):451-5. doi: 10.1097/00007611-200405000-00007.

  PMID: 15180019 BACKGROUND

• Chrysostomou C, Sanchez De Toledo J, Avolio T, Motoa MV, Berry D, Morell VO, Orr R, Munoz R. Dexmedetomidine use in a pediatric cardiac intensive care unit: can we use it in infants after cardiac surgery? Pediatr Crit Care Med. 2009 Nov;10(6):654-60. doi: 10.1097/PCC.0b013e3181a00b7a.

  PMID: 19295456 BACKGROUND

• Walker J, Maccallum M, Fischer C, Kopcha R, Saylors R, McCall J. Sedation using dexmedetomidine in pediatric burn patients. J Burn Care Res. 2006 Mar-Apr;27(2):206-10. doi: 10.1097/01.BCR.0000200910.76019.CF.

  PMID: 16566567 BACKGROUND

• Koroglu A, Demirbilek S, Teksan H, Sagir O, But AK, Ersoy MO. Sedative, haemodynamic and respiratory effects of dexmedetomidine in children undergoing magnetic resonance imaging examination: preliminary results. Br J Anaesth. 2005 Jun;94(6):821-4. doi: 10.1093/bja/aei119. Epub 2005 Mar 11.

  PMID: 15764627 BACKGROUND

• Berkenbosch JW, Wankum PC, Tobias JD. Prospective evaluation of dexmedetomidine for noninvasive procedural sedation in children. Pediatr Crit Care Med. 2005 Jul;6(4):435-9; quiz 440. doi: 10.1097/01.PCC.0000163680.50087.93.

  PMID: 15982430 BACKGROUND

• Chrysostomou C, Schulman SR, Herrera Castellanos M, Cofer BE, Mitra S, da Rocha MG, Wisemandle WA, Gramlich L. A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of dexmedetomidine in preterm and term neonates. J Pediatr. 2014 Feb;164(2):276-82.e1-3. doi: 10.1016/j.jpeds.2013.10.002. Epub 2013 Nov 14.

  PMID: 24238862 BACKGROUND

• Diaz SM, Rodarte A, Foley J, Capparelli EV. Pharmacokinetics of dexmedetomidine in postsurgical pediatric intensive care unit patients: preliminary study. Pediatr Crit Care Med. 2007 Sep;8(5):419-24. doi: 10.1097/01.PCC.0000282046.66773.39.

  PMID: 17693909 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hee-Soo Kim, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Professor

Model Details: Dexmedetomidine infusion at intensive care unit

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 22, 2019
• Study Start: August 14, 2019
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)