Target Controlled Infusion of PropofolVaSCoMNCT01492712
Validation Study of Covariates Model (VaSCoM) for Propofol
A study testing Propofol in people with Target Controlled Infusion of Propofol, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial summary
Anaesthesia for surgical procedures can be provided using a continuous infusion of intravenous drug. The most commonly used drug for this technique is propofol. Infusion devices programmed with pharmacokinetic models can be used to infuse propofol to achieve a target blood concentration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Target Controlled Infusion of Propofol
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Feb 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- ASA I/II
- Elective non-cardiac surgery expected to last longer than 30 minutes
Who cannot join
- Patient refusal or unable to consent
- Premedication, sedative or anaesthetic in the previous 12 hours
- Pre-operative GCS less than 15
- ASA III/IV
- Allergy to constituents of propofol
- Excess alcohol intake
Show all 10Show fewer
- Drug abuse
- Mental retardation
- Difficult airway
- BMI over 35
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, G81 4HX
About this study
Anaesthesia for surgical procedures can be provided using a continuous infusion of intravenous drug. The most commonly used drug for this technique is propofol. Infusion devices programmed with pharmacokinetic models can be used to infuse propofol to achieve a target blood concentration. These pharmacokinetic models predict the rate of distribution of propofol within the body and also the rate at which it is cleared. In practice, the anaesthetist enters patient details such as age, sex and weight as well as a target blood concentration of propofol. The infusion device then infuses propofol at the appropriate rate to achieve this concentration.
White and colleagues recently published the Covariates Model for propofol. It is anticipated that this model will have reduced bias and inaccuracy compared to the models in current clinical use. The VaSCoM study has three objectives:
Read more
- Prospective validation of the Covariates Model
- Modelling of the effect site concentration of propofol
- Comparison of propofol concentration in venous and arterial blood samples
To achieve the above objectives, patients over 18 years of age and undergoing elective non-cardiac surgery will be recruited to the study. Anaesthesia will be delivered using a target controlled infusion device programmed with the Covariates Model for propofol. The target blood concentrations will be set according to a pre-determined schedule and all measurements will be made prior to the start of surgery.
Prospective validation of the Covariates Model will be done by comparing blood concentration of propofol predicted by the model to those actually measured. These results will then be compared to the predictions made using the models in current clinical practice.
Modelling of the effect site means predicting the concentration of propofol in the brain for a given blood concentration. This will involve using depth of anaesthesia monitors (such as bispectral index) as surrogate markers of brain concentration and comparing this to the predicted and measured blood concentrations of propofol.
Finally, important information on the distribution and clearance of propofol can be gained through the comparison of venous and arterial blood samples. In this study, simultaneous sampling of venous and arterial blood will facilitate this comparison.
- Conditions
- Target Controlled Infusion of Propofol
- Being tested
- Propofol
- Keywords
- Propofol, Pharmacokinetics, Pharmacodynamics, Infusion Pumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Patients in the low-high-low group will receive an infusion of propofol with an initial blood target concentration of 2 mcg/ml. After 15 minutes the target will be increased to 5 mcg/ml and after a further 15 minutes the target will be reduced back to 2 mcg/ml for a further 15 to 30 minutes.
PropofolDrug
Patients in the high-low-high group will receive an infusion of propofol with an initial blood target concentration of 5 mcg/ml. After 15 minutes the target will be reduced to 2 mcg/ml and after a further 15 minutes the target will be increased back to 5 mcg/ml for a further 15 to 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Low-high-low blood target concentration | Experimental | Patients in the low-high-low group will receive an infusion of propofol with an initial blood target concentration of 2 mcg/ml. After 15 minutes the target will be increased to 5 mcg/ml and after a further 15 minutes the target will be reduced back to 2 mcg/ml for a further 15 to 30 minutes. Receives: Drug: Propofol |
| High-low-high target blood concentration | Experimental | Patients in the high-low-high group will receive an infusion of propofol with an initial blood target concentration of 5 mcg/ml. After 15 minutes the target will be reduced to 2 mcg/ml and after a further 15 minutes the target will be increased back to 5 mcg/ml for a further 15 to 30 minutes. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance error of predicted blood propofol concentration (venous blood samples)
Performance error is calculated as:
((Measured blood concentration - Predicted blood concentration)/ Predicted blood concentration) x 100
The median performance error and the absolute performance error can then be calculated as measures of bias and inaccuracy respectively.
Measured: 1.5, 5, 16.5, 20, 31.5, 35, 45-60 minutes post infusion start time
Secondary outcomes (2)
Depth of anaesthesia
Depth of anaesthesia (as measured by bispectral index and index of consciousness) will be used as a surrogate marker of propofol effect site concentration. By using complex statistical analysis to compare depth of anaesthesia to measured and predicted blood concentrations, we aim to determine the Keo. This is the rate constant for elimination of propofol from the effect site compartment and will be incorporated to the Covariates Model to predict brain concentration for a given blood concentration of propofol.
Measured: 0 to 45-60 minutes post infusion start time
Comparison of performance errors calculated from venous blood samples to performance errors calculated from arterial blood samples
Performance error is calculated as:
((Measured blood concentration - Predicted blood concentration)/ Predicted blood concentration) x 100
Measured: 1.5, 5, 16.5, 20, 31.5, 35, 45-60 minutes post infusion start time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Target Controlled Infusion of PropofolStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stefan Schraag, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492712
- Sponsor's protocol ID
- VaSCoM005
- Other IDs
- 2009-017900-10, 2009
- Acronym
- VaSCoM
- Status last verified
- Aug 2017
- First submitted
- 8 Dec 2011
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hawthorne C, Shaw M, Campbell R, Sutcliffe N, McKelvie S, Schraag S. Clinical Validation of the Covariates Pharmacokinetic Model for Propofol in an Adult Population. Drugs R D. 2022 Dec;22(4):289-300. doi: 10.1007/s40268-022-00404-4. Epub 2022 Oct 7.
PubMed 36207643
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Covariates Model (VaSCoM) for Propofol
- ClinicalTrials.gov ID
- NCT01492712
- Acronym / sponsor ID
- VaSCoM / VaSCoM005
- Conditions
- Target Controlled Infusion of Propofol
- Keywords
- Propofol, Pharmacokinetics, Pharmacodynamics, Infusion Pumps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Study start
- Jan 2011 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Dec 2011 (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.
Anaesthesia for surgical procedures can be provided using a continuous infusion of intravenous drug. The most commonly used drug for this technique is propofol. Infusion devices programmed with pharmacokinetic models can be used to infuse propofol to achieve a target blood concentration. These pharmacokinetic models predict the rate of distribution of propofol within the body and also the rate at which it is cleared. In practice, the anaesthetist enters patient details such as age, sex and weight as well as a target blood concentration of propofol. The infusion device then infuses propofol at the appropriate rate to achieve this concentration.
White and colleagues recently published the Covariates Model for propofol. It is anticipated that this model will have reduced bias and inaccuracy compared to the models in current clinical use. The VaSCoM study has three objectives:
- Prospective validation of the Covariates Model
- Modelling of the effect site concentration of propofol
- Comparison of propofol concentration in venous and arterial blood samples
To achieve the above objectives, patients over 18 years of age and undergoing elective non-cardiac surgery will be recruited to the study. Anaesthesia will be delivered using a target controlled infusion device programmed with the Covariates Model for propofol. The target blood concentrations will be set according to a pre-determined schedule and all measurements will be made prior to the start of surgery.
Prospective validation of the Covariates Model will be done by comparing blood concentration of propofol predicted by the model to those actually measured. These results will then be compared to the predictions made using the models in current clinical practice.
Modelling of the effect site means predicting the concentration of propofol in the brain for a given blood concentration. This will involve using depth of anaesthesia monitors (such as bispectral index) as surrogate markers of brain concentration and comparing this to the predicted and measured blood concentrations of propofol.
Finally, important information on the distribution and clearance of propofol can be gained through the comparison of venous and arterial blood samples. In this study, simultaneous sampling of venous and arterial blood will facilitate this comparison.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-high-low blood target concentration | Experimental | Drug: PropofolPatients in the low-high-low group will receive an infusion of propofol with an initial blood target concentration of 2 mcg/ml. After 15 minutes the target will be increased to 5 mcg/ml and after a further 15 minutes the target will be reduced back to 2 mcg/ml for a further 15 to 30 minutes. |
| High-low-high target blood concentration | Experimental | Drug: PropofolPatients in the high-low-high group will receive an infusion of propofol with an initial blood target concentration of 5 mcg/ml. After 15 minutes the target will be reduced to 2 mcg/ml and after a further 15 minutes the target will be increased back to 5 mcg/ml for a further 15 to 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18 years
- ASA I/II
- Elective non-cardiac surgery expected to last longer than 30 minutes
Key exclusion criteria (10 listed)
- Patient refusal or unable to consent
- Premedication, sedative or anaesthetic in the previous 12 hours
- Pre-operative GCS less than 15
- ASA III/IV
- Allergy to constituents of propofol
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 |
|---|---|---|
| PropofolPatients in the low-high-low group will receive an infusion of propofol with an initial blood target concentration of 2 mcg/ml. After 15 minutes the target will be increased to 5 mcg/ml and after a further 15 minutes the target will be reduced back to 2 mcg/ml for a further 15 to 30 minutes. | Drug | Low-high-low blood target concentration |
| PropofolPatients in the high-low-high group will receive an infusion of propofol with an initial blood target concentration of 5 mcg/ml. After 15 minutes the target will be reduced to 2 mcg/ml and after a further 15 minutes the target will be increased back to 5 mcg/ml for a further 15 to 30 minutes. | Drug | High-low-high target blood concentration |
Primary outcome
Performance error of predicted blood propofol concentration (venous blood samples)
Time frame: 1.5, 5, 16.5, 20, 31.5, 35, 45-60 minutes post infusion start time
Performance error is calculated as: ((Measured blood concentration - Predicted blood concentration)/ Predicted blood concentration) x 100 The median performance error and the absolute performance error can then be calculated as measures of bias and inaccuracy respectively.
2 secondary outcomes
Depth of anaesthesia
Time frame: 0 to 45-60 minutes post infusion start time
Comparison of performance errors calculated from venous blood samples to performance errors calculated from arterial blood samples
Time frame: 1.5, 5, 16.5, 20, 31.5, 35, 45-60 minutes post infusion start time
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 14 Aug 2017.
- Derived from this study: PubMed 36207643Hawthorne C, Shaw M, Campbell R, Sutcliffe N, McKelvie S, Schraag S. Clinical Validation of the Covariates Pharmacokinetic Model for Propofol in an Adult Population. Drugs R D. 2022 Dec;22(4):289-300. doi: 10.1007/s40268-022-00404-4. Epub 2022 Oct 7.
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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.
Stefan Schraag principal investigator
Golden Jubilee National 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 Propofol in people with Target Controlled Infusion of Propofol, run by Golden Jubilee National Hospital 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 3 inclusion and 10 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 14 Aug 2017. 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?
Performance error of predicted blood propofol concentration (venous blood samples) (time frame: 1.5, 5, 16.5, 20, 31.5, 35, 45-60 minutes post infusion start time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492712, which also lists 1 linked publication.
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 14 Aug 2017.