Effect of Dexmedetomidine on Sevoflurane in Young Children
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
This study is testing how different doses of a medication called Dexmedetomidine can change the amount of anesthesia needed for young children during surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 1 Month to 36 Months |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03384563 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how two different dosages of Dexmedetomidine (0.5mcg/kg and 1mcg/kg) influence the minimum alveolar concentration (MAC) of Sevoflurane in children aged 1 month to 3 years. The MAC is a critical measure of anesthetic potency, indicating the dose required to prevent movement in response to surgical stimuli. By assessing the effects of Dexmedetomidine on MAC, the study seeks to optimize anesthesia protocols for pediatric patients undergoing surgery. The research will involve children from three age groups: 1-6 months, 6-12 months, and 12-36 months.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 month to 3 years who are scheduled for surgery.
Not a fit: Patients with significant comorbidities such as congenital heart disease, central nervous system disorders, or those with a history of difficult intubation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia management in young children, enhancing safety and efficacy during surgical procedures.
How similar studies have performed: Previous studies have shown that Dexmedetomidine can effectively reduce the MAC of inhalational anesthetics in adults, suggesting potential success in pediatric applications.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Rahul Baijal, MD — Baylor College of Medicine
- Study coordinator: Margaret Owens-Stuberfield
- Email: owensstu@bcm.edu
- Phone: 832-824-5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.