Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2020
CompletedJune 12, 2020
June 1, 2020
4 months
June 8, 2020
June 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of intubation
as assessed by vocal cord movement
At intubation time
Study Arms (2)
Dexmedetomidine
EXPERIMENTALhave 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(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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- parents refusal
- Allergy to drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehab Abd Elraof Abd Elaziz
Alexandria, Smouha, 000000, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rehab A. Abd Elaziz, Ass.Prof.
Alexandria University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant Professor of Anesthesia
Study Record Dates
First Submitted
June 8, 2020
First Posted
June 11, 2020
Study Start
June 1, 2020
Primary Completion
September 20, 2020
Study Completion
October 20, 2020
Last Updated
June 12, 2020
Record last verified: 2020-06