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

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.

Study Overview

• Status: Recruiting
• Conditions: Extubation
• Intervention / Treatment: Other: Total intravenous anesthesia (TIVA); Other: Sevoflurane initiated intravenous anesthesia (SIIVA)

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Wes Templeton, MD; Phone Number: 336-716-4498; Email: ttemplet@wakehealth.edu
• Study Contact Backup: Name: Lynne Harris, BSN; Phone Number: 336-716-8791; Email: lcharris@wakehealth.edu

Study Locations

• Australia
  • Perth, Australia
    • Not yet recruiting
    • Perth Children's Hospital
    • Contact: Britta von Ungern-Sternberg, Prof; Phone Number: +61(0)8 6456 4806
    • Contact: Lliana Slevin; Phone Number: +61(0)8 6456 4806; Email: Lliana.Slevin@health.wa.gov.au
• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist
      • Contact: Lynnette C Harris, BSN; Phone Number: 336-716-8791; Email: lcharris@wakehealth.edu
      • Contact: Thomas "Wes" Templeton, MD; Phone Number: 336-716-4498; Email: ttemplet@wakehealth.edu
      • Principal Investigator: Thomas "Wes" Templeton, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All study participants must be < 10 years of age and undergoing general anesthesia and surgery with an endotracheal tube and using a SIIVA or TIVA approach

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Total intravenous anesthesia (TIVA); TIVA anesthetic -no inhalational gases for surgery
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.	Other: Sevoflurane initiated intravenous anesthesia (SIIVA); SIIVA - sevoflurane anesthetic gases for surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation success rate	quality of extubation will be assess using a standard rubric for all extubation	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of extubation that requiring intervention	desaturation, laryngospasm, airway obstruction or other issues	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects that met specific extubation criteria	Assess the presence of specific extubation criteria met during the extubation	Day 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Thomas "Wes" Templeton, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: anesthesia; Propofol; inhalational agents
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane; Anesthetics
• Other Study ID Numbers: IRB00092312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No