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OpenTrials
Completed

NCT Number: NCT04150432

Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children

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.

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Key information

Conditions

Eye Diseases

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective eye surgey

Exclusion criteria

  • known propofol hypersensitivity

Treatment and study plan

Edmon

Device

New device for exhaled propofol concentration measurements

Primary outcomes

  1. Propofol plasma concentration versus simultaneous exhaled concentration

    Time frame: 5 hours

    repeated blood samples of propofol concentration

  2. Realtionship between Paedfusor-estimated propofol concentration and measured concentration in plasma samples

    Time frame: During general anaesthesia

Secondary outcomes

  1. Propofol exhaled correlation versus Bispectral Index value (BIS)

    Time frame: 5 hours

    repeated blood samples of propofol concentration

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 4, 2019
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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