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

Extubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837936
• Other study ID #: IRB00092312
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: March 2028

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Wes Templeton, MD
• Phone: 336-716-4498
• Email: ttemplet[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Years

Eligibility

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)

Related Conditions & MeSH terms

• Extubation

Intervention

Other:
• Total intravenous anesthesia (TIVA)
TIVA anesthetic -no inhalational gases for surgery
• Sevoflurane initiated intravenous anesthesia (SIIVA)
SIIVA - sevoflurane anesthetic gases for surgery

Locations

Country	Name	City	State
Australia	Perth Children's Hospital	Perth
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects that met specific extubation criteria	Assess the presence of specific extubation criteria met during the extubation	Day 1
Primary	Extubation success rate	quality of extubation will be assess using a standard rubric for all extubation	Day 1
Secondary	Rate of extubation that requiring intervention	desaturation, laryngospasm, airway obstruction or other issues	Day 1