Evaluating anesthesia methods in young patients
Official title: A Prospective Observational Study Evaluating Extubation Criteria in Children Less 10 Years of Age and Younger Undergoing Intravenous Anesthesia
Run by Wake Forest University Health Sciences · NCT05837936 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 9 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 2 sites (Winston-Salem, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | March 28, 2023 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | December 18, 2025 |
| Trial ID | NCT05837936 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric patients under 10 years old scheduled for surgeries requiring general anesthesia with TIVA or SIIVA.
✕Probably not a fit
Patients with a history of home oxygen use, ventilator dependence, or specific contraindications to Propofol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this study could improve extubation outcomes and safety for pediatric patients undergoing anesthesia.
How similar studies have gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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On-hours vs off-hours extubation: comparing acute airway problems after extubation
This study tests whether extubations done during on-hours have fewer acute airway/respiratory problems in the first 30 minutes after extubation compared with extubations done off-hours in adults undergoing general anesthesia.
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Endotracheal suctioning during positive-pressure extubation in the ICU
This tests whether doing endotracheal suctioning during positive-pressure extubation helps adults on mechanical ventilation have better oxygenation (ROX) three hours after extubation.
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This test will see if a one-hour pressure-support or T-piece breathing trial helps overweight and obese adults on a ventilator be successfully extubated without needing reintubation within 72 hours.
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High-flow nasal cannula versus non-invasive ventilation after extubation in children following heart surgery
This compares high-flow nasal cannula and non-invasive ventilation to see which better prevents reintubation in children after heart surgery.
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Using electrical stimulation at acupoints to reduce respiratory issues after anesthesia
This study is testing if electrical stimulation at certain points on the body can help people recover better from anesthesia by improving their breathing and preventing problems.
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This study is trying to find out how often problems happen after removing breathing tubes in patients who have had surgery or are critically ill, to help make the process safer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.