AnesthesiaNCT04771702
Expired Propofol in Low Back Surgery
A study testing Edmon in people with Anesthesia, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Edmon (BBraun, Germany) is a portable, commercially available device for measurement of propofol in exhaled air. The study will aim at evaluating the sensitivity and specificity of such exhaled propofol values compared with plasma propofol and measures of anaesthetic and antinociceptive effect. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Edmon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 14 Jan 2021to Dec 2024
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective patients scheduled for low-back surgery
- BMI between 20 -32 kg/m2
- ASA I-II
- Written informed concent
Who cannot join
- Contraindication to propofol TCI
- Use of psychopharmaco or neurologic disease
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, 0407
Johan Raeder, +47 92249669, johan.rader@medisin.uio.no
Johan Raeder
About this study
Official title: Propofol Measurement in Expiration Air and Monitoring of EEG and Pain in Patients Undergoing Low Back Surgery
Edmon (BBraun, Germany) is a portable, commercially available device for measurement of propofol in exhaled air.
The study will aim at evaluating the sensitivity and specificity of such exhaled propofol values compared with plasma propofol and measures of anaesthetic and antinociceptive effect.
Read the detailed description
Elective low-back surgery patients will be induced for general intubation anesthesia with propofol and remifentanil.
After induction a 20 min period of stable propofol infusion only will be established before start of surgery. The patients will be monitored for exhaled propofol, plasma propofol (blood samples), continous frontal EEG, Bispectral Index (BIS), skin conductance, estimated (computer based) concentrations of plasma and effect site propofol, and skin conductance.
After start of surgery (with ongoing propofol and restart of remifentanil TCI) the monitoring will continue in order to explore these relationships further.
- Conditions
- Anesthesia
- Being tested
- Edmon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdmonDevice
Exhaled air will be analyzed for propofol
| Study group | Role | What they receive |
|---|---|---|
| Edmon arm | Experimental | Not described Receives: Device: Edmon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled air versus plasma concentration
Measured: per-operative
Secondary outcomes (3)
EEG recording
EEG will be recorded and compared with plasma propofol, exhaled propofol and BIS
Measured: per-operative
Exhaled propofol 2
Exhaled propofol versus dose given, estimated plasma concentration, estimated effect site concentration
Measured: per-operative
Nociceptive stimulation
Skin conductance versus plasma and exhaled propofol concentration
Measured: per-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start14 Jan 2021
- Primary completionJun 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention is to have patients in 20 min stable anaesthesia before start of surgery in order to validate the use of exhaled propofol versus pharmakokinetic modelling and measured plasma concentration
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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 S Thagaard, MD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771702
- Sponsor's protocol ID
- Edmon-Oslo-Low Back Surgery
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Measurement in Expiration Air and Monitoring of EEG and Pain in Patients Undergoing Low Back Surgery
- ClinicalTrials.gov ID
- NCT04771702
- Acronym / sponsor ID
- Edmon-Oslo-Low Back Surgery
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Feb 2021 (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.
Edmon (BBraun, Germany) is a portable, commercially available device for measurement of propofol in exhaled air.
The study will aim at evaluating the sensitivity and specificity of such exhaled propofol values compared with plasma propofol and measures of anaesthetic and antinociceptive effect.
Detailed description
Elective low-back surgery patients will be induced for general intubation anesthesia with propofol and remifentanil.
After induction a 20 min period of stable propofol infusion only will be established before start of surgery. The patients will be monitored for exhaled propofol, plasma propofol (blood samples), continous frontal EEG, Bispectral Index (BIS), skin conductance, estimated (computer based) concentrations of plasma and effect site propofol, and skin conductance.
After start of surgery (with ongoing propofol and restart of remifentanil TCI) the monitoring will continue in order to explore these relationships further.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention is to have patients in 20 min stable anaesthesia before start of surgery in order to validate the use of exhaled propofol versus pharmakokinetic modelling and measured plasma concentration
| Arm | Type | Receives |
|---|---|---|
| Edmon arm | Experimental | Device: Edmon |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elective patients scheduled for low-back surgery
- BMI between 20 -32 kg/m2
- ASA I-II
- Written informed concent
Key exclusion criteria (3 listed)
- Contraindication to propofol TCI
- Use of psychopharmaco or neurologic disease
- Pregnancy or breast feeding
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 |
|---|---|---|
| EdmonExhaled air will be analyzed for propofol | Device | Edmon arm |
Primary outcome
Exhaled air versus plasma concentration
Time frame: per-operative
3 secondary outcomes
EEG recording
Time frame: per-operative
Exhaled propofol 2
Time frame: per-operative
Nociceptive stimulation
Time frame: per-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- 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 S 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 Anesthesia, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Raeder, PhD (004792249669, johan.rader@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled air versus plasma concentration (time frame: per-operative). 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 25 Feb 2021.