NCT05837936

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Mar 2023Mar 2028

Study Start

First participant enrolled

March 28, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

4.9 years

First QC Date

April 3, 2023

Last Update Submit

December 10, 2025

Conditions

Extubation

Keywords

anesthesiaPropofolinhalational agents

Outcome Measures

Primary Outcomes (1)

  • Extubation success rate

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

    Day 1

Secondary Outcomes (1)

  • Rate of extubation that requiring intervention

    Day 1

Other Outcomes (1)

  • Number of Subjects that met specific extubation criteria

    Day 1

Study Arms (2)

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)

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)

Interventions

Total intravenous anesthesia (TIVA)OTHER

TIVA anesthetic -no inhalational gases for surgery

Total intravenous anesthesia (TIVA)
Sevoflurane initiated intravenous anesthesia (SIIVA)OTHER

SIIVA - sevoflurane anesthetic gases for surgery

Sevoflurane initiated intravenous anesthesia (SIIVA)

Eligibility Criteria

AgeUp to 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Perth Children's Hospital

Perth, Australia

NOT YET RECRUITING

Study Officials

  • Thomas "Wes" Templeton, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wes Templeton, MD

CONTACT

336-716-4498ttemplet@wakehealth.edu

Lynne Harris, BSN

CONTACT

336-716-8791lcharris@wakehealth.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

May 1, 2023

Study Start

March 28, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

US(1)AU(1)