Evaluating anesthesia methods in young patients
A Prospective Observational Study Evaluating Extubation Criteria in Children Less 10 Years of Age and Younger Undergoing Intravenous Anesthesia
This study is testing how different anesthesia methods affect young patients' breathing and recovery after surgery to find the best ways to safely wake them up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | N/A to 9 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 2 sites (Winston-Salem, North Carolina and 1 other locations) |
| Trial ID | NCT05837936 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the predictive value of extubation criteria in pediatric patients receiving Total Intravenous Anesthesia (TIVA) or Sevoflurane initiated intravenous anesthesia (SIIVA). It focuses on how these different anesthetic regimens, which have distinct pharmacologic mechanisms, may influence airway reflexes and ventilation during the extubation process. By examining patients under 10 years of age undergoing elective or emergency surgeries with planned airway instrumentation, the study seeks to identify optimal extubation criteria tailored to these anesthesia techniques.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 10 years old scheduled for surgeries requiring general anesthesia with TIVA or SIIVA.
Not a fit: Patients with a history of home oxygen use, ventilator dependence, or specific contraindications to Propofol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve extubation outcomes and safety for pediatric patients undergoing anesthesia.
How similar studies have performed: While there is ongoing research in anesthesia techniques, this specific approach to evaluating extubation criteria in pediatric patients using TIVA and SIIVA is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients \<10 years of age * Undergoing elective or emergency surgery with planned airway instrumentation with an endotracheal tube (ETT) * Patients having general anesthesia with a planned SIIVA or TIVA technique * Patients with an end tidal agent concentration of Sevoflurane\<0.1% at the time of emergence and extubation * following sevoflurane induction to place IV Exclusion Criteria: * History of home oxygen use or ventilator dependence * Patients with cyanotic congenital heart disease * Patients undergoing anesthesia for imaging procedures alone * Patients intended to be managed with supraglottic airway * Patients having an anesthesia time \< 30 minutes * Monitored Anesthesia Care (not general anesthesia) * Patients with contraindication to receiving Propofol (i.e. mitochondrial myopathy)
Where this trial is running
Winston-Salem, North Carolina and 1 other locations
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
- Perth Children's Hospital — Perth, Australia (Not_yet_recruiting)
Study contacts
- Principal investigator: Thomas "Wes" Templeton, MD — Wake Forest University Health Sciences
- Study coordinator: Wes Templeton, MD
- Email: ttemplet@wakehealth.edu
- Phone: 336-716-4498
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.