Clinical trial NCT05837936: Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients
Official title: A Prospective Observational Study Evaluating Extubation Criteria in Children Less 10 Years of Age and Younger Undergoing Intravenous Anesthesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extubation
Keywords: anesthesia
Propofol
inhalational agents
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 600
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study participants must be \< 10 years of age and undergoing general anesthesia and surgery with an endotracheal tube and using a SIIVA or TIVA approach

Brief summary: Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.

Detailed description: This is because these anesthetic regimens have different pharmacologic mechanisms of actions, and therefore interact with central nervous system in different ways leading to potentially the need for different extubation criteria in patients receiving TIVA or SIIVA. Additionally, intravenous agents likely have less of an effect on airway reflexes and ventilation at light levels of anesthesia. This study is proposing an observational study to examine the predictive value of various extubation criteria in the setting of SIIVA and TIVA.

Eligibility 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)

Primary outcomes:
measure: Extubation success rate
timeFrame: Day 1
Secondary outcomes:
measure: Rate of extubation that requiring intervention
timeFrame: Day 1
Other outcomes:
measure: Number of Subjects that met specific extubation criteria
timeFrame: Day 1
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Perth
country: Australia
facility: Perth Children's Hospital
Study officials:
affiliation: Wake Forest University Health Sciences
name: Thomas "Wes" Templeton, MD
role: PRINCIPAL_INVESTIGATOR
References: