Trials / Completed
CompletedNCT04150432
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 3 Years – 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edmon | New device for exhaled propofol concentration measurements |
Timeline
- Start date
- 2019-10-30
- Primary completion
- 2020-06-30
- Completion
- 2021-06-30
- First posted
- 2019-11-04
- Last updated
- 2026-03-09
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT04150432. Inclusion in this directory is not an endorsement.