Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation

A

Alexandria University

Status and phase

Unknown
Phase 2

Conditions

Craniofacial Abnormalities
Mandibular Hypoplasia

Treatments

Drug: dexmedetomidine
Drug: sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT04426552
0304285

Details and patient eligibility

About

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

Full description

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

Enrollment

40 estimated patients

Sex

All

Ages

1 to 3 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA physical status I and II
  • aged 1 year to 3 years
  • require general anaesthesia with tracheal intubation for surgical correction of the congenital or acquired pathology that created the difficult airway

Exclusion criteria

  • parents refusal
  • Allergy to drugs

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Dexmedetomidine
Experimental group
Description:
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
Treatment:
Drug: dexmedetomidine
Sevoflurane
Active Comparator group
Description:
(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
Treatment:
Drug: sevoflurane

Trial contacts and locations

1

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Central trial contact

Rehab A. Abd Elaziz, Ass. Prof.

Data sourced from clinicaltrials.gov

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