Recruiting

TIVA & SIIVA

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05837936

Conditions

Extubation

Eligibility Criteria

Sex: All

Age: 0 - 9

Healthy Volunteers: Not accepted

Interventions

Total intravenous anesthesia (TIVA)

Sevoflurane initiated intravenous anesthesia (SIIVA)

Study Details

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.

Conditions

Extubation

Study ID

NCT05837936

Start date

Mar 28, 2023

Status verified date

Dec, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 9

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Total intravenous anesthesia (TIVA)

TIVA is achieved without inhalational agents and may be performed in cases where patients have an intravenous line in place prior to induction of anesthesia

Sevoflurane initiated intravenous anesthesia (SIIVA)

SIIVA is a modification of TIVA in the setting where a patient does not tolerate the insertion of an intravenous line prior to induction of anesthesia. The patient undergoes induction of anesthesia with sevoflurane and transition to Propofol IV anesthesia for maintenance once the intravenous line is in place and discontinues the inhalational agent, sevoflurane.

Interventions

Total intravenous anesthesia (TIVA)

TIVA anesthetic -no inhalational gases for surgery

Sevoflurane initiated intravenous anesthesia (SIIVA)

SIIVA - sevoflurane anesthetic gases for surgery

Primary outcome measure

  • Extubation success rate [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Wes Templeton, MD

336-716-4498ttemplet@wakehealth.edu

Lynne Harris, BSN

336-716-8791lcharris@wakehealth.edu

Locations

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Thomas "Wes" Templeton, MD

336-716-4498ttemplet@wakehealth.edu

Lynnette C Harris, BSN

336-716-8791lcharris@wakehealth.edu

Principal Investigator:

Thomas "Wes" Templeton, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

  • anesthesia
  • Propofol
  • inhalational agents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-12-18.