General AnaesthesiaNCT01549639
Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion
An observational study of General Anaesthesia and Propofol, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit and the operating room. The pharmacokinetics of propofol are difficult to predict in patients not conforming to the norms in which the original pharmacokinetic research was based. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- General Anaesthesia, Propofol, Target Controlled Infusion
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Jun 2012
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated in the Operating Theatre undergoing propofol intravenous anaesthesia who require an arterial line to be inserted as standard care.
Who may be able to join
- Only patients undergoing major surgery where blood sampling through arterial or central venous catheters is part of their routine clinical care will be recruited.
- Only patients undergoing total intravenous anaesthesia using propofol will be recruited.
Who cannot join
- Anaemic patients will not be recruited into the study.
- Patients unable to consent will not be recruited into the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
About this study
Official title: Use of a Novel Point of Care Device to Measure Blood Propofol Levels During Propofol Based General Anesthesia by Target Controlled Infusion Using the Marsh Model in Effect Site Mode
Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit and the operating room. The pharmacokinetics of propofol are difficult to predict in patients not conforming to the norms in which the original pharmacokinetic research was based. Such patients, including the critically ill, and morbidly obese, are increasingly being encountered. The investigators group have been involved in the development of a device which can measure blood propofol concentrations, and hope for this to be available to use in the operating room in a clinically useful timeframe in the future. Data will be collected on patients undergoing propofol based general anaesthesia. The Marsh target controlled algorithm in effect site mode (commonly used by anaesthetists) will be assessed for accuracy using the propofol monitor. A new proportional correction method will be developed using this data, designed to enable recalibration of the TCI algorithm in near real time in order to achieve a more accurate estimated propofol concentration in these identified patient groups. The research will investigate the effectiveness of a correction of estimated propofol levels based on a one off measurement early on in the anaesthetic, and will take subsequent samples to measure propofol levels without modifying the TCI algorithm. Additionally, data on anaesthetist choice of TCI model, and method of administration in this relatively unselected group of patients will be analysed.
- Keywords
- Propofol, Target controlled infusion, General anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Anaesthesia | Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias)
Measured: duration of anaesthesia (up to 24 hours)
Secondary outcomes (2)
Median absolute percentage prediction error of estimated propofol concentration compared to measured concentrations (inaccuracy)
Measured: duration of anaesthesia (up to 24 hours)
Change in median percentage prediction error(bias)for propofol levels measured beyond thirty minutes following proportional correction at thirty minutes
Measured: thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnaesthesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas J Cowley, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Nicholas J Cowley, MRCP FRCA, Principal investigator, University Hospital Birmingham NHS Foundation TrustThomas Clutton-Brock, FRCA FRCP, Study chair, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549639
- Sponsor's protocol ID
- rrk4342
- Status last verified
- Jul 2012
- First submitted
- 2 Mar 2012
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Point of Care Device to Measure Blood Propofol Levels During Propofol Based General Anesthesia by Target Controlled Infusion Using the Marsh Model in Effect Site Mode
- ClinicalTrials.gov ID
- NCT01549639
- Acronym / sponsor ID
- rrk4342
- Keywords
- Propofol, Target controlled infusion, General anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Mar 2012 (estimated)
- 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.
Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit and the operating room. The pharmacokinetics of propofol are difficult to predict in patients not conforming to the norms in which the original pharmacokinetic research was based. Such patients, including the critically ill, and morbidly obese, are increasingly being encountered. The investigators group have been involved in the development of a device which can measure blood propofol concentrations, and hope for this to be available to use in the operating room in a clinically useful timeframe in the future. Data will be collected on patients undergoing propofol based general anaesthesia. The Marsh target controlled algorithm in effect site mode (commonly used by anaesthetists) will be assessed for accuracy using the propofol monitor. A new proportional correction method will be developed using this data, designed to enable recalibration of the TCI algorithm in near real time in order to achieve a more accurate estimated propofol concentration in these identified patient groups. The research will investigate the effectiveness of a correction of estimated propofol levels based on a one off measurement early on in the anaesthetic, and will take subsequent samples to measure propofol levels without modifying the TCI algorithm. Additionally, data on anaesthetist choice of TCI model, and method of administration in this relatively unselected group of patients will be analysed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Anaesthesia | – | –Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated in the Operating Theatre undergoing propofol intravenous anaesthesia who require an arterial line to be inserted as standard care.
Key inclusion criteria (2 listed)
- Only patients undergoing major surgery where blood sampling through arterial or central venous catheters is part of their routine clinical care will be recruited.
- Only patients undergoing total intravenous anaesthesia using propofol will be recruited.
Key exclusion criteria (2 listed)
- Anaemic patients will not be recruited into the study.
- Patients unable to consent will not be recruited into the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias)
Time frame: duration of anaesthesia (up to 24 hours)
2 secondary outcomes
Median absolute percentage prediction error of estimated propofol concentration compared to measured concentrations (inaccuracy)
Time frame: duration of anaesthesia (up to 24 hours)
Change in median percentage prediction error(bias)for propofol levels measured beyond thirty minutes following proportional correction at thirty minutes
Time frame: thirty minutes
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 19 Jul 2012.
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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.
Nicholas J Cowley, MRCP FRCA principal investigator
University Hospital Birmingham NHS Foundation Trust
Thomas Clutton-Brock, FRCA FRCP study chair
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anaesthesia and Propofol, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 2 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 19 Jul 2012. 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 United Kingdom. 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?
Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias) (time frame: duration of anaesthesia (up to 24 hours)). 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 19 Jul 2012.