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| Name | Class |
|---|---|
| Ministry of Food and Drug Safety, Korea | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Intravenous infusion of dexmedetomidine for 50 min after surgery at intensive care unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of arrhythmia | Presence of any kind of arrhythmia from electrocardiogram following dexmedetomidine infusion | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion |
| Non-invasive blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee-Soo Kim, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongro Gu | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17273114 | Background | 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. | |
| 20718689 | 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. |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Dexmedetomidine infusion at intensive care unit
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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
| 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 | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion |
| Respiratory rate | Respiratory rate in units of /min, to examine whether respiratory depression or apnea occurs | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion |
| Incidence of nausea | Incidence of nausea following dexmedetomidine infusion | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion |
| Incidence of vomiting | Incidence of vomiting following dexmedetomidine infusion | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion |
| 19430081 | 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. |
| 28952341 | 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. |
| 27516413 | 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. |
| 24824958 | Background | Plambech MZ, Afshari A. Dexmedetomidine in the pediatric population: a review. Minerva Anestesiol. 2015 Mar;81(3):320-32. Epub 2014 May 14. |
| 26012345 | 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. |
| 26170346 | 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. |
| 15180019 | 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. |
| 19295456 | 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. |
| 16566567 | 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. |
| 15764627 | 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. |
| 15982430 | 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. |
| 24238862 | 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. |
| 17693909 | 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. |