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NCT Number: NCT05837936

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

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.

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Key information

Conditions

Age range

Up to 9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Perth Children's Hospital, Perth, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Total Intravenous Anesthesia (TIVA)

Other

TIVA anesthetic -no inhalational gases for surgery

Sevoflurane initiated intravenous anesthesia (SIIVA)

Other

SIIVA - sevoflurane anesthetic gases for surgery

Primary outcomes

  1. Extubation success rate

    Time frame: Day 1

    quality of extubation will be assess using a standard rubric for all extubation

Secondary outcomes

  1. Rate of extubation that requiring intervention

    Time frame: Day 1

    desaturation, laryngospasm, airway obstruction or other issues

Other outcomes

  1. Number of Subjects that met specific extubation criteria

    Time frame: Day 1

    Assess the presence of specific extubation criteria met during the extubation

Study contacts

Contact information is provided by the study sponsor or research team.

Lynne Harris, BSN

CONTACT

[email protected]

336-716-8791

Wes Templeton, MD

CONTACT

[email protected]

336-716-4498

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 1, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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