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

Recruiting

• Conditions: Extubation
• Interventions: Other: Sevoflurane initiated intravenous anesthesia (SIIVA); Other: Total intravenous anesthesia (TIVA)

• Registration Number: NCT05837936
• Lead Sponsor: Wake Forest University Health Sciences

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.

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 Timeline

• Study Start: 2023-03-28
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sevoflurane initiated intravenous anesthesia (SIIVA)	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.
Total intravenous anesthesia (TIVA)	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

Primary Outcome Measures

Name	Time	Method
Extubation success rate	Day 1	quality of extubation will be assess using a standard rubric for all extubation

Secondary Outcome Measures

Name	Time	Method
Rate of extubation that requiring intervention	Day 1	desaturation, laryngospasm, airway obstruction or other issues

Trial Locations

Locations (2)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States

Perth Children's Hospital; 🇦🇺 Perth, Australia