MedDataX Logo

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

NCT ID: NCT05837936

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-28

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Extubation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

anesthesia Propofol inhalational agents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Total intravenous anesthesia (TIVA)

Intervention Type OTHER

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.

Sevoflurane initiated intravenous anesthesia (SIIVA)

Intervention Type OTHER

SIIVA - sevoflurane anesthetic gases for surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Total intravenous anesthesia (TIVA)

TIVA anesthetic -no inhalational gases for surgery

Intervention Type OTHER

Sevoflurane initiated intravenous anesthesia (SIIVA)

SIIVA - sevoflurane anesthetic gases for surgery

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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)
Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas "Wes" Templeton, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Perth Children's Hospital

Perth, , Australia

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wes Templeton, MD

Role: CONTACT

Phone: 336-716-4498

Email: [email protected]

Lynne Harris, BSN

Role: CONTACT

Phone: 336-716-8791

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thomas "Wes" Templeton, MD

Role: primary

Lynnette C Harris, BSN

Role: backup

Britta von Ungern-Sternberg, Prof

Role: primary

Lliana Slevin

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00092312

Identifier Type: -

Identifier Source: org_study_id