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Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients

A Prospective Observational Study Evaluating Extubation Criteria in Children Less 10 Years of Age and Younger Undergoing Intravenous Anesthesia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05837936
Enrollment
600
Registered
2023-05-01
Start date
2023-03-28
Completion date
2028-03-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation

Keywords

anesthesia, Propofol, inhalational agents

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.

Interventions

TIVA anesthetic -no inhalational gases for surgery

OTHERSevoflurane initiated intravenous anesthesia (SIIVA)

SIIVA - sevoflurane anesthetic gases for surgery

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 9 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Extubation success rateDay 1quality of extubation will be assess using a standard rubric for all extubation

Secondary

MeasureTime frameDescription
Rate of extubation that requiring interventionDay 1desaturation, laryngospasm, airway obstruction or other issues

Other

MeasureTime frameDescription
Number of Subjects that met specific extubation criteriaDay 1Assess the presence of specific extubation criteria met during the extubation

Countries

Australia, United States

Contacts

Primary ContactWes Templeton, MD
ttemplet@wakehealth.edu336-716-4498
Backup ContactLynne Harris, BSN
lcharris@wakehealth.edu336-716-8791

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026