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Is exhaled propofol concentration influenced by mechanical ventilation settings?

Influence of mechanical ventilation settings on breath-by-breath exhaled propofol concentration during general anesthesia: a pharmacokinetic study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032230398
Enrollment
30
Registered
2023-10-16
Start date
2023-10-16
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Elective surgical procedure

Interventions

1. Selection of anesthesia method (total intravenous anesthesia with propofol) 2. Mechanical ventilator settings during surgery
Anesthesia, Intravenous

Sponsors

Masui Kenichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 30 scheduled surgery patients aged 18 and over who are hospitalized at Yokohama City University Hospital (10 aged 18-49, 10 aged 50-69, 10 aged 70 and over. 5 males and 5 females in each age group) 2) Patients who are expected to undergo general anesthesia for more than 3 hours 3) Supine position, general anesthesia patient under double lung ventilation 4) Patients undergoing invasive arterial pressure catheter insertion 5) Patients who have given their written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1) Patients contraindicated for administration of propofol 2) Patients whose ASA classification, which is the general condition classification of the American Society of Anesthesiologists, is class 4 or higher 3) Surgery with head low or high at 25 degrees or more 4) Patients with interstitial pneumonia, COPD, pulmonary edema, severe cardiac dysfunction, severe liver dysfunction 5) Pregnant women (lactating women)

Design outcomes

Primary

MeasureTime frame
Prediction Error (PEex) calculated using estimated end tidal expiratory propofol concentration and measured plasma propofol. PEex is defined as (measured plasma propofol concentration - end tidal propofol concentration)/end tidal propofol concentration or measured plasma propofol concentration/end tidal propofol concentration.

Secondary

MeasureTime frame
The PEex derivatives, pharmacokinetic indices median prediction error (MDPE) and median absolute prediction error (MDAPE), are used to assess the performance of end tidal propofol concentration as a predicted value of plasma propofol concentration. If respiratory conditions influence prediction error, prediction formula will be developed to improve the predictive performance of plasma propofol concentrations using end tidal propofol concentration. The time course of PEex is illustrated. Prediction error of measured plasma propofol concentration vs predicted plasma propofol concentration is calculated as (measured plasma propofol concentration-predicted plasma propofol concentration)/predicted plasma propofol concentration, or as measured plasma propofol concentration/predicted plasma propofol concentration. MDPE and MDAPE are also calculated using predicted plasma concentartion determined using the Marsh model. The time course of the prediction error is dipicted. The end tidal propofol concentration and predicted plasma propofol concentration as predictive values of measured plasma propofol vconcentration are compared.

Contacts

Public ContactTomonori Tsuchiya

Yokohama City University Hospital

yiu41707@yokohama-cu.ac.jp+81-45-787-2918

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026