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Intensive Care UnitPhase 2NCT04027829

Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

A Phase 2 study testing Dexmedetomidine Hydrochloride in people with Intensive Care Unit and Postoperative Care, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 18 years
Conditions the study is for
Intensive Care Unit, Postoperative Care
What is being tested?
Dexmedetomidine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSouth Korea
Study dates
14 Aug 2019to 14 Nov 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, Jongro Gu, 03080

Other trials in South Korea

About this study

Official title: Pharmacokinetic-pharmacodynamic Analysis for Dosing Strategy and Evaluation of Safety and Efficacy 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.

Read the 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.

Being tested
Dexmedetomidine Hydrochloride
Keywords
dexmedetomidine, pediatric, sedation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine HydrochlorideDrug

    Also called Precedex

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

Study groups in NCT04027829
Study groupRoleWhat they receive
DexmedetomidineExperimentalIntravenous infusion of dexmedetomidine for 50 min after surgery at intensive care unit
Receives: Drug: Dexmedetomidine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Bispectral index

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

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

  3. 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)

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

Secondary outcomes (6)

  1. Incidence of arrhythmia

    Presence of any kind of arrhythmia from electrocardiogram following dexmedetomidine infusion

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

  2. 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

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

  3. Incidence of desaturation

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

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

  4. Respiratory rate

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

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

  5. Incidence of nausea

    Incidence of nausea following dexmedetomidine infusion

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

  6. Incidence of vomiting

    Incidence of vomiting following dexmedetomidine infusion

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2019
  2. Study start14 Aug 2019
  3. Primary completion14 Nov 2019
  4. Study completion14 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Dexmedetomidine infusion at intensive care unit
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04027829
Sponsor's protocol ID
1905-188-1037
Status last verified
Apr 2020
First submitted
8 Jul 2019
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17273114

  • 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.

    PubMed 20718689

  • 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.

    PubMed 19430081

  • 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.

    PubMed 28952341

  • 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.

    PubMed 27516413

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

    PubMed 24824958

  • 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.

    PubMed 26012345

  • 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.

    PubMed 26170346

  • 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.

    PubMed 15180019

  • 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.

    PubMed 19295456

  • 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.

    PubMed 16566567

  • 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.

    PubMed 15764627

  • 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.

    PubMed 15982430

  • 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.

    PubMed 24238862

  • 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.

    PubMed 17693909

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexmedetomidine Hydrochloride in people with Intensive Care Unit and Postoperative Care, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma concentration of dexmedetomidine (time frame: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04027829, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.

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