RecruitingNCT05837936

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


Sponsor

Wake Forest University Health Sciences

Enrollment

600 participants

Start Date

Mar 28, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 9 Years

Plain Language Summary

Simplified for easier understanding

This study compares two intravenous anesthesia techniques — Total Intravenous Anesthesia (TIVA) and Sevoflurane-Initiated Intravenous Anesthesia (SIIVA) — in children under 10 years old undergoing surgery requiring a breathing tube. Both techniques use intravenous drugs (primarily propofol) to maintain anesthesia after the initial induction, but SIIVA begins with brief sevoflurane inhalation to establish IV access before switching to intravenous drugs. The study examines outcomes such as how smoothly children wake up from anesthesia, how quickly they recover, and whether there are any complications. Children under 10 years old undergoing elective or emergency surgery with planned endotracheal intubation who are receiving a TIVA or SIIVA anesthesia technique are eligible. Children using home oxygen, those with cyanotic congenital heart disease, those undergoing imaging-only procedures, or those planned for a supraglottic airway are excluded. Surgeries shorter than 30 minutes are also excluded. Children who cannot receive propofol due to mitochondrial disease are excluded. Pediatric anesthesia is technically challenging and carries unique risks compared to adults. Emergence agitation — distressing, thrashing wakefulness immediately after surgery — is common in young children and can cause injury and significant family distress. Understanding which intravenous maintenance technique leads to smoother, calmer emergence could directly improve the experience and safety of surgery for millions of children each year.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTotal intravenous anesthesia (TIVA)

TIVA anesthetic -no inhalational gases for surgery

OTHERSevoflurane initiated intravenous anesthesia (SIIVA)

SIIVA - sevoflurane anesthetic gases for surgery


Locations(2)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Perth Children's Hospital

Perth, Australia

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NCT05837936


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