Actively Recruiting
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane in Children Aged 1 Month to 3 Years
Led by Baylor College of Medicine · Updated on 2025-09-22
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of two doses of Dexmedetomidine (0.5 mcg/kg and 1 mcg/kg) on the minimum alveolar concentration (MAC) of Sevoflurane in children aged between 1 month and 3 years. The MAC is the amount of anesthetic needed to prevent movement in half of patients during surgery. Since age affects MAC in children, this study aims to understand how Dexmedetomidine, a sedative with potential neuroprotective properties, influences Sevoflurane dosage in this young population. Participants receive Dexmedetomidine intravenously over 10 minutes before surgery at either 0.5 mcg/kg or 1 mcg/kg, or a saline placebo, followed by an assigned concentration of Sevoflurane. The trial is randomized and includes multiple groups divided by age ranges: 1-6 months, 6-12 months, and 1-3 years. The study compares these dosing regimens to observe the impact on Sevoflurane anesthesia requirements. During the study, researchers monitor participants' movement immediately after skin incision to measure anesthetic effect. Safety and response to anesthesia are closely observed, with attention to potential influences on MAC from patient factors or medications. The trial runs until the end of 2025, with detailed assessments during surgery to evaluate how Dexmedetomidine changes Sevoflurane needs in young children.
CONDITIONS
Brief Title
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 month to 3 years presenting for surgery
You will not qualify if you...
- Interstitial lung disease, chest wall disease, or bronchospastic disease with recent flare-ups in the past 2 weeks
- History of difficult intubation or ventilation
- Airway malformation
- Congenital heart disease
- Cardiac arrhythmias
- Central nervous system disease including developmental delay, cerebral palsy, or seizure disorder
- History or family history of malignant hyperthermia
- Electrolyte disorders
- Gastrointestinal disease
- Hepatic dysfunction
- Renal dysfunction
- Metabolic diseases such as diabetes
- Obesity defined as body mass index greater than the 95th percentile for age
- Preterm infant (less than 37 weeks gestational age)
- Use of medications that may affect MAC such as anticonvulsants, opioids, benzodiazepines, antibiotics, antihistamines, or drugs inducing hepatic enzymes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (day of surgery)
Participants receive a single dose of Dexmedetomidine or placebo intravenously over 10 minutes prior to surgery and are administered an assigned concentration of Sevoflurane during the surgical procedure.
1 visit (in-person, day of surgery)
Duration - Immediately following surgery
Participants are monitored immediately following the surgical procedure to assess movement response and recovery.
1 visit (in-person, post-surgery)
Trial Site Locations
Total: 1 location
1
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Margaret Owens-Stuberfield
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
9
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