A Phase 2 interventional study of dexmedetomidine and sevoflurane in Craniofacial Abnormalities and Mandibular Hypoplasia, sponsored by Alexandria University. Status unknown at 1 site in Egypt. Open to participants aged 1 Year to 3 Years. Per ClinicalTrials.gov, last updated 2020-06-12.
Sponsored by Alexandria University · Phase 2, Interventional, and Diagnostic
difficult problem in the paediatric age group because of their small mouth opening and un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as benzodiazepines, propofol or opioids may cause respiratory depression, especially when used in high doses
Dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is clearly a great advantage in handling a critical (unstable, difficult) airway while inducing sedation in both adult and infants. The aim is to compare intubation conditions between dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients with an anticipated difficult intubation
Exclusion Criteria:
have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI
Drug: dexmedetomidine
(sevoflurane) will be preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation
Drug: sevoflurane
will have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI
preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation
Assessment of intubation
as assessed by vocal cord movement
Time frame: At intubation time
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Alexandria University