ConditionPediatric Anesthesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-36
SponsorBaylor College of Medicine
About this trial
The purpose of this protocol is to determine the effect of two clinically applicable Dexmedetomidine dosages (0.5mcg/kg and 1mcg/kg) on the minimum alveolar concentration (MAC) of Sevoflurane in children between the age ranges of: 1-6 months; 6-12 months of age and 12 months-36 months years of age.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Interstitial lung disease, chest wall disease, or bronchospastic disease with no flare-ups in the past 2 weeks of presentation
History of difficult intubation or ventilation
Airway malformation
Congenital heart disease
Trial design
Design model
Single group
Treatments tested in this trial
Dexmedetomidine
DrugDexmedetomidine 9 arms
Treatment groups
180 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Dexmedetomidine 0.5 mcg/kg 1-6 monthsActive comparator 1 intervention
Group B: Dexmedetomidine 1 mcg/kg 1-6 monthsActive comparator 1 intervention
Group C: Dexmedetomidine 0.5 mcg/kg 6-12 monthsActive comparator 1 intervention
Group D: Dexmedetomidine 1 mcg/kg 6-12 monthsActive comparator 1 intervention
Group E: Placebo 6-12 monthsPlacebo comparator 1 intervention
Group F: Dexmedetomidine 0.5 mcg/kg 1-3 yearsActive comparator 1 intervention
Group G: Dexmedetomidine 1 mcg/kg 1-3 yearsActive comparator 1 intervention
Group H: Placebo 1-3 yearsPlacebo comparator 1 intervention
Group I: Placebo 1-6 monthsPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Movement
The study is completed after assessment of patient movement with skin incision
Time frame
Immediately following skin incisionSponsors and contacts
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Source ClinicalTrials.gov