Eye DiseasesNCT04150432
Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children
A study testing Edmon in people with Eye Diseases, run by Oslo University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Edmon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- 30 Oct 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- elective eye surgey
Who cannot join
- known propofol hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propofol in Expiratory Air, a Comparison With Plasma Propofol, BIS Value and Calculated Plasma Concentration During General Anesthesia 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.
Read the 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
- Eye Diseases
- Being tested
- Edmon
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdmonDevice
New device for exhaled propofol concentration measurements
| Study group | Role | What they receive |
|---|---|---|
| propofol | Experimental | propofol general anesthesia, exhaled measurement of propofol Receives: Device: Edmon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol plasma concentration versus simultaneous exhaled concentration
repeated blood samples of propofol concentration
Measured: 5 hours
Realtionship between Paedfusor-estimated propofol concentration and measured concentration in plasma samples
Measured: During general anaesthesia
Secondary outcomes (1)
Propofol exhaled correlation versus Bispectral Index value (BIS)
repeated blood samples of propofol concentration
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start30 Oct 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Consecutive patients will participate in the study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan C Ræder, Oslo University Hospital
- Investigators
- Kristin Thagaard, MD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150432
- Sponsor's protocol ID
- Exhaled propofol Children
- Status last verified
- Mar 2026
- First submitted
- 30 Oct 2019
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol in Expiratory Air, a Comparison With Plasma Propofol, BIS Value and Calculated Plasma Concentration During General Anesthesia in Children
- ClinicalTrials.gov ID
- NCT04150432
- Acronym / sponsor ID
- Exhaled propofol Children
- Conditions
- Eye Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consecutive patients will participate in the study
| Arm | Type | Receives |
|---|---|---|
| propofol | Experimental | Device: Edmonpropofol general anesthesia, exhaled measurement of propofol |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- elective eye surgey
Key exclusion criteria (1 listed)
- known propofol hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdmonNew device for exhaled propofol concentration measurements | Device | propofol |
Primary outcome
Propofol plasma concentration versus simultaneous exhaled concentration
Time frame: 5 hours
repeated blood samples of propofol concentration
Realtionship between Paedfusor-estimated propofol concentration and measured concentration in plasma samples
Time frame: During general anaesthesia
1 secondary outcome
Propofol exhaled correlation versus Bispectral Index value (BIS)
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Thagaard, MD study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edmon in people with Eye Diseases, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol plasma concentration versus simultaneous exhaled concentration (time frame: 5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.