Back to resultsDexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation
Primary Purpose
Craniofacial Abnormalities, Mandibular Hypoplasia
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
dexmedetomidine
sevoflurane
Sponsored by
About this trial
This is an interventional diagnostic trial for Craniofacial Abnormalities
Eligibility Criteria
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
Sites / Locations
- Rehab Abd Elraof Abd ElazizRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexmedetomidine
Sevoflurane
Arm Description
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) 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
Outcomes
Primary Outcome Measures
Assessment of intubation
as assessed by vocal cord movement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04426552
Brief Title
Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation
Official Title
Dexmedetomidine Versus Sevoflurane Inhalation for Fibreoptic Nasotracheal Intubation in Children With Anticipated Difficult Intubation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Anticipated)
Study Completion Date
October 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniofacial Abnormalities, Mandibular Hypoplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
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
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
(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
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of intubation
Description
as assessed by vocal cord movement
Time Frame
At intubation time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab A. Abd Elaziz, Ass. Prof.
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab A. Abd Elaziz, Ass.Prof.
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab Abd Elraof Abd Elaziz
City
Alexandria
State/Province
Smouha
ZIP/Postal Code
000000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab A. Abd Elaziz, Ass. Prof.
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation
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