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

Last updated: January 27, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Total intravenous anesthesia (TIVA)

Sevoflurane initiated intravenous anesthesia (SIIVA)

Clinical Study ID

NCT05837936
IRB00092312
  • Ages < 9
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Pediatric patients <10 years of age

  • Undergoing elective or emergency surgery with planned airway instrumentation with anendotracheal 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 ofemergence and extubation

  • following sevoflurane induction to place IV

Exclusion

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)

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Total intravenous anesthesia (TIVA)
Phase:
Study Start date:
March 28, 2023
Estimated Completion Date:
March 31, 2028

Study 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.

Connect with a study center

  • Perth Children's Hospital

    Perth,
    Australia

    Site Not Available

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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