Clinical trial Recruiting at 1 site Observational Ages Any age to 9

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 typeObservational
AgesAny age to 9 Years
SexAll
Enrollment600 (estimated)
SponsorWake Forest University Health Sciences
Academic / other
Locations2 sites (Winston-Salem, North Carolina and 1 other locations)
StatusRecruiting
StartedMarch 28, 2023
Main results expectedMarch 2028
Study endsMarch 2028
Registry record updatedDecember 18, 2025
Trial IDNCT05837936 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.