Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
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.
Conditions:
🦠 Pediatric Anesthesia
🗓️ Study Start (Actual) 18 February 2018
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 180
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

Exclusion Criteria:

  • 1. Interstitial lung disease, chest wall disease, or bronchospastic disease with no flare-ups in the past 2 weeks of presentation
  • 2. History of difficult intubation or ventilation
  • 3. Airway malformation
  • 4. Congenital heart disease
  • 5. Cardiac arrhythmias
  • 6. Central nervous system disease, including developmental delay, cerebral palsy, or seizure disorder
  • 7. History of or family history of malignant hyperthermia
  • 8. Electrolyte disorders
  • 9. Gastrointestinal disease
  • 10. Hepatic dysfunction
  • 11. Renal dysfunction
  • 12. Metabolic disease, such as diabetes
  • 13. Obesity, defined as a body mass index greater than the 95% percentile for age
  • 14. Preterm infant (less than 37 weeks gestational age) 15. Use of any medications (anticonvulsants, opioids, benzodiazepines, antibiotics, antihistamines drugs that induce hepatic enzymes) that may affect MAC.
  • Inclusion Criteria
  • All patients age 1 month- 3 years presenting for surgery.
Ages Eligible for Study: 1 Month to 36 Months (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 December 2017
  • First Submitted that Met QC Criteria 19 December 2017
  • First Posted 27 December 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 May 2024
  • Last Update Posted 23 May 2024
  • Last Verified May 2024