Dexmedetomidine Versus Sevoflurane Inhalation for Fibreoptic Nasotracheal Intubation in Children With Anticipated Difficult Intubation
| Registry | NCT04426552 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: single, diagnostic |
| Enrollment | 40 (Estimated) |
| Sponsor | Alexandria University (Other) |
| Conditions | Craniofacial Abnormalities, Mandibular Hypoplasia |
| Interventions | dexmedetomidine, sevoflurane (Drug) |
| Dates | start 2020-06-01, primary completion 2020-09-20 (estimated), completion 2020-10-20 (estimated), first posted 2020-06-11, last updated 2020-06-12 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Craniofacial Abnormalities All trials for Mandibular Hypoplasia All trials of dexmedetomidine All trials of sevoflurane
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dexmedetomidine | Experimental | Drug: 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 |
| Sevoflurane | Active comparator | Drug: 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 |
Sex: All, ages: 1 Year to 3 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Rehab Abd Elraof Abd Elaziz | Alexandria, Smouha | Egypt | Recruiting |