Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation

Phase 2

• Conditions: Craniofacial Abnormalities; Mandibular Hypoplasia
• Interventions: Drug: sevoflurane; Drug: dexmedetomidine

• Registration Number: NCT04426552
• Lead Sponsor: Alexandria University

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

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-11
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-12
• Primary Completion: 2020-09-20
• Study Completion: 2020-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	sevoflurane	(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
Dexmedetomidine	dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
Assessment of intubation	At intubation time	as assessed by vocal cord movement

Trial Locations

Locations (1)

Rehab Abd Elraof Abd Elaziz; 🇪🇬 Alexandria, Smouha, Egypt