Bariatric Surgery CandidateNCT03817541
Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients
A study testing Edmon (reg), BBraun in people with Bariatric Surgery Candidate and Cholecystectomy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared With concommitant plasma samples of propofol Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Cholecystectomy
- What is being tested?
- Edmon (reg), BBraun
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 14 Nov 2018to 31 Dec 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients admitted to Oslo University Hospital, scheduled for elective laparoscopic bariatric surgery or elective laparoscopic cholecystectomy.
- Both genders.
- Age 18-60 years, both inclusive.
- BMI ≥ 20 kg/m2, 10 patients with BMI 20-30, and 10 patients with BMI > 40
- ASA classification I-III
Who cannot join
- • Known hypersensitivity or other contraindication to propofol administered as Target Controlled Infusion.
- Patients which during a preoperative visit are deemed not to tolerate propofol bolus or infusion as administered by Target Controlled Infusion.
- Ongoing neuroleptic medication.
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: Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients
Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared With concommitant plasma samples of propofol
Read the detailed description
Edmon (trade mark) is a New Device from BBraun, measuring the expiratory concentration of propofol in anaesthetized patients.
The investigators will test the accuracy and stability of such measurements in comparison With plasma propofol Levels.
The investigators will test during target Control infusion (Marsh model) and assumed stable plasma Levels.
Plasma samples of propofol will be taken for comparison With exhaled propofol.
- Conditions
- Bariatric Surgery Candidate, Cholecystectomy
- Being tested
- Edmon (reg), BBraun
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edmon (reg), BBraunDevice
Also called propofol plasma sample
exhaled propofol will be compared With plasma propofol values
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Experimental | Patients due for bariatric surgery, BMI > 30 Receives: Device: Edmon (reg), BBraun |
| Cholecystectomy | Experimental | Normal weight patients due for cholecystectomies Receives: Device: Edmon (reg), BBraun |
What is being measured
The primary outcome is the main question the study is designed to answer.
exhaled propofol concentration
parts per billion
Measured: start of anaesthesia to end of anaesthesia, 2-3 hours in total
propofol plasma concentration
microg pr ml
Measured: 4-6 samples in the period between start and end of anaesthesia
Secondary outcomes (5)
calculated plasma concentration
Marsh model prediction, microg pr ml
Measured: From start of anaesthesia until end of anaesthesia, 1-3 hrs in total
BIS
Bispectral index value, score = 0-100
Measured: from start of anaesthesia until end of anaestheisa, 1-3 hours in total
calculated effect site concentration
Marsh model, microg pr ml
Measured: from start of anaesthesia until end of anaesthesia, 1-3 hours in total
EEG Power spectrum
Spectral edge value (Hz)
Measured: f
EEG Power distribution
% representation relative Power of Alpha, Beta, Theta, Gamma band
Measured: from start of anaesthesia until end of anaesthesia, 1-3 hours in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start14 Nov 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomy
- Masking
- None (open label)
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817541
- Sponsor's protocol ID
- Expiratory propofol gastro
- Status last verified
- Feb 2019
- First submitted
- 18 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients
- ClinicalTrials.gov ID
- NCT03817541
- Acronym / sponsor ID
- Expiratory propofol gastro
- Conditions
- Bariatric Surgery Candidate, Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 25 Jan 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.
Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared With concommitant plasma samples of propofol
Detailed description
Edmon (trade mark) is a New Device from BBraun, measuring the expiratory concentration of propofol in anaesthetized patients.
The investigators will test the accuracy and stability of such measurements in comparison With plasma propofol Levels.
The investigators will test during target Control infusion (Marsh model) and assumed stable plasma Levels.
Plasma samples of propofol will be taken for comparison With exhaled propofol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomy
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Experimental | Device: Edmon (reg), BBraunPatients due for bariatric surgery, BMI > 30 |
| Cholecystectomy | Experimental | Device: Edmon (reg), BBraunNormal weight patients due for cholecystectomies |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients admitted to Oslo University Hospital, scheduled for elective laparoscopic bariatric surgery or elective laparoscopic cholecystectomy.
Key exclusion criteria (3 listed)
- • Known hypersensitivity or other contraindication to propofol administered as Target Controlled Infusion.
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 |
|---|---|---|
| Edmon (reg), BBraunAlso: propofol plasma sampleexhaled propofol will be compared With plasma propofol values | Device | Bariatric surgery, Cholecystectomy |
Primary outcome
exhaled propofol concentration
Time frame: start of anaesthesia to end of anaesthesia, 2-3 hours in total
parts per billion
propofol plasma concentration
Time frame: 4-6 samples in the period between start and end of anaesthesia
microg pr ml
5 secondary outcomes
calculated plasma concentration
Time frame: From start of anaesthesia until end of anaesthesia, 1-3 hrs in total
BIS
Time frame: from start of anaesthesia until end of anaestheisa, 1-3 hours in total
calculated effect site concentration
Time frame: from start of anaesthesia until end of anaesthesia, 1-3 hours in total
EEG Power spectrum
Time frame: f
EEG Power distribution
Time frame: from start of anaesthesia until end of anaesthesia, 1-3 hours in total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, Norway
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 (reg), BBraun in people with Bariatric Surgery Candidate and Cholecystectomy, 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 5 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 5 Feb 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exhaled propofol concentration (time frame: start of anaesthesia to end of anaesthesia, 2-3 hours in total). 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 5 Feb 2019.