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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05837936




Registration number
NCT05837936
Ethics application status
Date submitted
3/04/2023
Date registered
1/05/2023
Date last updated
15/03/2024

Titles & IDs
Public title
Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients
Scientific title
A Prospective Observational Study Evaluating Extubation Criteria in Children Less 10 Years of Age and Younger Undergoing Intravenous Anesthesia
Secondary ID [1] 0 0
IRB00092312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extubation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Total intravenous anesthesia (TIVA)
Other interventions - Sevoflurane initiated intravenous anesthesia (SIIVA)

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

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 interventions: Total intravenous anesthesia (TIVA)
TIVA anesthetic -no inhalational gases for surgery

Other interventions: Sevoflurane initiated intravenous anesthesia (SIIVA)
SIIVA - sevoflurane anesthetic gases for surgery
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Extubation success rate
Timepoint [1] 0 0
Day 1
Secondary outcome [1] 0 0
Rate of extubation that requiring intervention
Timepoint [1] 0 0
Day 1

Eligibility
Key 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
Minimum age
No limit
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
Wake Forest University Health Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT05837936
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas "Wes" Templeton, MD
Address 0 0
Wake Forest University Health Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wes Templeton, MD
Address 0 0
Country 0 0
Phone 0 0
336-716-4498
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05837936