Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane

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 volunteers

Qualifiers

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

    Drug

    Dexmedetomidine 9 arms

Treatment groups

180 Participants
are divided into 9 treatment groups

9

Treatment groups

See 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 incision

Secondary outcomes

Other outcomes

Sponsors and contacts

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