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NCT05837936 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design

Related Conditions & MeSH terms

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
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