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NCT04150432 Clinical Trial

Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children

Eye Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04150432
Other study ID # Exhaled propofol Children
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2019
Est. completion date December 31, 2021

Study information
Verified date October 2019
Source Oslo University Hospital
Contact Johan Raeder, PhD, MD
Phone 004792249669
Email johan.rader@medisin.uio.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 31, 2021
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 3 Years to 10 Years
Eligibility Inclusion Criteria:

- elective eye surgey

Exclusion Criteria:

- known propofol hypersensitivity

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Edmon
New device for exhaled propofol concentration measurements

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Propofol plasma concentration versus simultaneous exhaled concentration repeated blood samples of propofol concentration 5 hours
Secondary Propofol exhaled correlation versus Bispectral Index value (BIS) repeated blood samples of propofol concentration 5 hours
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