Document Detail

A dose-response study of dexmedetomidine administered as the primary sedative in infants following open heart surgery.
MedLine Citation:
PMID:  23628837     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the dose-response relationship of dexmedetomidine in infants with congenital heart disease postoperative from open heart surgery.
DESIGN: Prospective open-label dose-escalation pharmacokinetic-pharmacodynamic study.
SETTING: Tertiary pediatric cardiac ICU.
PATIENTS: Thirty-six evaluable infants, 1-24 months old, postoperative from open heart surgery requiring mechanical ventilation.
INTERVENTIONS: Cohorts of 12 infants were enrolled sequentially to one of the three IV loading doses of dexmedetomidine (0.35, 0.7, and 1 mcg/kg) over 10 minutes followed by respective continuous infusions (0.25, 0.5, and 0.75 mcg/kg/hr) for up to 24 hours.
MEASUREMENTS AND MAIN RESULTS: Dexmedetomidine plasma concentrations were obtained at timed intervals during and following discontinuation of infusion. Pharmacodynamic variables evaluated included sedation scores, supplemental sedation and analgesia medication administration, time to tracheal extubation, respiratory function, and hemodynamic parameters. Infants achieved a deeper sedation measured by the University of Michigan Sedation Scale score (2.6 vs 1) despite requiring minimal supplemental sedation (0 unit doses/hr) and fewer analgesic medications (0.07 vs 0.15 unit doses/hr) while receiving dexmedetomidine compared with the 12-hour follow-up period. Thirty-one patients were successfully extubated while receiving the dexmedetomidine infusion. Only one patient remained intubated due to oversedation during the infusion. While receiving dexmedetomidine, there was a decrease in heart rate compared with baseline, 132 versus 161 bpm, but there was an increase in heart rate compared with postinfusion values, 132 versus 128 bpm. There was no statistically or clinically significant change in mean arterial blood pressure.
CONCLUSIONS: Dexmedetomidine administration in infants following open heart surgery can provide improved sedation with reduction in supplemental medication requirements, leading to successful extubation while receiving a continuous infusion. The postoperative hemodynamic changes that occur in infants postoperative from open heart surgery are multifactorial. Although dexmedetomidine may play a role in decreasing heart rate immediately postoperative, the changes were not clinically significant and did not fall below postinfusion heart rates.
Felice Su; Susan C Nicolson; Athena F Zuppa
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies     Volume:  14     ISSN:  1529-7535     ISO Abbreviation:  Pediatr Crit Care Med     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-07-22     Completed Date:  2014-03-14     Revised Date:  2014-06-03    
Medline Journal Info:
Nlm Unique ID:  100954653     Medline TA:  Pediatr Crit Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  499-507     Citation Subset:  IM    
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MeSH Terms
Airway Extubation
Cardiac Surgical Procedures*
Dexmedetomidine / administration & dosage*,  blood,  pharmacokinetics
Dose-Response Relationship, Drug
Heart Defects, Congenital / surgery*
Hemodynamics / drug effects*
Hypnotics and Sedatives / administration & dosage*,  blood,  pharmacokinetics
Infusions, Intravenous / methods*
Intensive Care Units
Postoperative Care / methods*
Prospective Studies
Statistics, Nonparametric
Grant Support
L40 HL082468/HL/NHLBI NIH HHS; L40 HL082468-02/HL/NHLBI NIH HHS; M01 RR000240/RR/NCRR NIH HHS; M01 RR000240-42/RR/NCRR NIH HHS; U10 HD037255/HD/NICHD NIH HHS; U10 HD037255-09/HD/NICHD NIH HHS
Reg. No./Substance:
0/Hypnotics and Sedatives; 67VB76HONO/Dexmedetomidine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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