Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation

Craniofacial Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04426552
• Other study ID #: 0304285
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: October 20, 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: Rehab A. Abd Elaziz, Ass. Prof.
• Phone: 01001073703
• Email: trcium2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniofacial Abnormalities
• Mandibular Hypoplasia

Intervention

Drug:
• dexmedetomidine
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
• sevoflurane
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

Locations

Country	Name	City	State
Egypt	Rehab Abd Elraof Abd Elaziz	Alexandria	Smouha

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of intubation	as assessed by vocal cord movement	At intubation time