Effect of Three pediatric propofol TCI models on BIS monitored depth of anesthesia during proton therapy: a three-period crossover study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260106005

Enrollment

Registered

2026-01-06

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients aged 3 to 15 years undergoing proton therapy Target controlled infusion, Paedfusor, Kataria, Elevald, proton therapy

Interventions

TCI with Paedfusor model, target at 4 mcg/ml,TCI with Kataria model, target at 4 mcg/ml,TCI with Elevated model, target at 4 mcg/ml

Active Comparator Device,Active Comparator Device,Active Comparator Device

Paedfusor,Kataria,Elevald

Eligibility

Sex/Gender

All

Age

3 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 3 to 15 years undergoing proton therapy

Exclusion criteria

Exclusion criteria: 1. Patient who is allergic to propofol 2. Patient with weight variation more than 2 kilograms during the period of study 3. Patient with anticipated or suspected difficult airway 4. Patient with obstructive sleep apnea or suspected of obstructive sleep apnea 5. Patient with risk of aspiration 6. Patient with difficult intravenous access or is needed inhalation induction 7. Patient who is not response to verbal command such as deafness or delayed development

Design outcomes

Primary

Measure	Time frame
The ratio of duration with bispectral index levels within the range of 40 to 60 compared to the total duration of propofol administration. during the operation Bispectral index	—

Secondary

Measure	Time frame
Oxygen saturation during the operation Pulse oximetry,Pulse rate during the operation Pulse oximetry,End tidal carbon dioxide during the operation End tidal gas sampling,Patient movement during the operation Observation,Airway obstruction during the operation Observation,Time to response Time from propofol cessation to patient awakening Time from propofol cessation to patient awakening,Time to reach BIS less than 60 ime from propofol infusion to BIS less than 60 Time from propofol infusion to BIS less than 60,Time to verbal unresponsiveness Time from propofol infusion to patient response to verbal command Time from propofol infusion to patient response to verbal command,Time to awake Time from propofol cessation to patient awakening Time from propofol cessation to patient awakening	—

Measure

Time frame

Oxygen saturation during the operation Pulse oximetry,Pulse rate during the operation Pulse oximetry,End tidal carbon dioxide during the operation End tidal gas sampling,Patient movement during the operation Observation,Airway obstruction during the operation Observation,Time to response Time from propofol cessation to patient awakening Time from propofol cessation to patient awakening,Time to reach BIS less than 60 ime from propofol infusion to BIS less than 60 Time from propofol infusion to BIS less than 60,Time to verbal unresponsiveness Time from propofol infusion to patient response to verbal command Time from propofol infusion to patient response to verbal command,Time to awake Time from propofol cessation to patient awakening Time from propofol cessation to patient awakening

—

Countries

Thailand

Contacts

Public ContactPaweena Paarporn

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn university

pw_jiam@hotmail.com6622564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026