Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation

Dexmedetomidine Versus Sevoflurane Inhalation for Fibreoptic Nasotracheal Intubation in Children With Anticipated Difficult Intubation

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04426552

Enrollment

Registered

2020-06-11

Start date

2020-06-01

Completion date

2020-10-20

Last updated

2020-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniofacial Abnormalities, Mandibular Hypoplasia

Brief summary

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

Detailed 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

Interventions

DRUGdexmedetomidine

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

DRUGsevoflurane

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Years to 3 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of intubation	At intubation time	as assessed by vocal cord movement

Countries

Egypt

Contacts

Primary ContactRehab A. Abd Elaziz, Ass. Prof.

trcium2002@yahoo.com01001073703

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026