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Status unknownNCT04426552Updated Jun 12, 2020

Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation

A Phase 2 interventional study of dexmedetomidine and sevoflurane in Craniofacial Abnormalities and Mandibular Hypoplasia, sponsored by Alexandria University. Status unknown at 1 site in Egypt. Open to participants aged 1 Year to 3 Years. Per ClinicalTrials.gov, last updated 2020-06-12.

Sponsored by Alexandria University · Phase 2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Year to 3 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Craniofacial Abnormalities
  • Mandibular Hypoplasia
03

Who can participate

Ages eligible
1 Year to 3 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • parents refusal
  • Allergy to drugs
04

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    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

    Drug: dexmedetomidine

  • Active comparator
    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

    Drug: sevoflurane

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

05

What researchers measure

Primary outcomes

  1. Assessment of intubation

    as assessed by vocal cord movement

    Time frame: At intubation time

06

Study locations

1 of 1 sites recruiting
  • Rehab Abd Elraof Abd Elaziz
    Alexandria, Smouha 000000, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT04426552
Lead sponsor
Alexandria University
Responsible party
rehab zayed (Assisstant Professor of Anesthesia, Alexandria University) — Principal investigator
First posted
Jun 11, 2020
Start date
Jun 1, 2020
Primary completion
Sep 20, 2020 (estimated)
Completion
Oct 20, 2020 (estimated)
Last update
Jun 12, 2020

Study contacts

Rehab A. Abd Elaziz, Ass. Prof.
Contact
trcium2002@yahoo.com
01001073703 ext. 020
Rehab A. Abd Elaziz, Ass.Prof.
principal investigator · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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