MedPath

Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children

Not Applicable
Conditions
Eye Diseases
Interventions
Device: Edmon
Registration Number
NCT04150432
Lead Sponsor
Oslo University Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
Inclusion Criteria
  • elective eye surgey
Exclusion Criteria
  • known propofol hypersensitivity

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
propofolEdmonpropofol general anesthesia, exhaled measurement of propofol
Primary Outcome Measures
NameTimeMethod
Propofol plasma concentration versus simultaneous exhaled concentration5 hours

repeated blood samples of propofol concentration

Secondary Outcome Measures
NameTimeMethod
Propofol exhaled correlation versus Bispectral Index value (BIS)5 hours

repeated blood samples of propofol concentration

Trial Locations

Locations (1)

Oslo University Hospital

🇳🇴

Oslo, Norway

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