Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children

Propofol in Expiratory Air, a Comparison With Plasma Propofol, BIS Value and Calculated Plasma Concentration During General Anesthesia in Children

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04150432

Enrollment

Registered

2019-11-04

Start date

2019-10-30

Completion date

2021-06-30

Last updated

2026-03-09

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

Conditions

Eye Diseases

Brief summary

Children due for elective eye surgery in propofol based anesthesia will be kept at steady state propofol infusion for maintenance, ventilation via endotracheal tube. Exhaled propofol will be measured continously by Edmon (R) (BBraun) monitor and compared with arterial plasma samples of propofol, drawn 3-5 times during the procedure.

Detailed description

The primary objective of the study is to determine the correlation between simultaneous concentrations of propofol in plasma and expiratory air in children during general anesthesia. Key secondary objectives include correlating plasma and exhaled measurements of propofol with electroencephalogram (BIS) values and computer estimated propofol concentrations in plasma and brain (TCI: target control infusion) Primary endpoint: Exhaled air and plasma concentration ratios of propofol during general anesthesia in children.

Interventions

DEVICEEdmon

New device for exhaled propofol concentration measurements

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Consecutive patients will participate in the study

Eligibility

Sex/Gender

ALL

Age

3 Years to 10 Years

Healthy volunteers

Inclusion criteria

* elective eye surgey

Exclusion criteria

* known propofol hypersensitivity

Design outcomes

Primary

Measure	Time frame	Description
Propofol plasma concentration versus simultaneous exhaled concentration	5 hours	repeated blood samples of propofol concentration
Realtionship between Paedfusor-estimated propofol concentration and measured concentration in plasma samples	During general anaesthesia	—

Secondary

Measure	Time frame	Description
Propofol exhaled correlation versus Bispectral Index value (BIS)	5 hours	repeated blood samples of propofol concentration

Countries

Norway

Contacts

STUDY_DIRECTORKristin Thagaard, MD

Oslo University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026