Validation Study of Covariates Model (VaSCoM) for Propofol
VaSCoM
2 other identifiers
interventional
40
1 country
1
Brief 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. 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:
- 1.Prospective validation of the Covariates Model
- 2.Modelling of the effect site concentration of propofol
- 3.Comparison of propofol concentration in venous and arterial blood samples
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 14, 2017
August 1, 2017
2.1 years
December 8, 2011
August 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1.5, 5, 16.5, 20, 31.5, 35, 45-60 minutes post infusion start time
Secondary Outcomes (2)
Depth of anaesthesia
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
1.5, 5, 16.5, 20, 31.5, 35, 45-60 minutes post infusion start time
Study Arms (2)
Low-high-low blood target concentration
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged over 18 years
- ASA I/II
- Elective non-cardiac surgery expected to last longer than 30 minutes
You may not qualify if:
- 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
- Drug abuse
- Mental retardation
- Difficult airway
- BMI over 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Golden Jubilee National Hospital
Clydebank, G81 4HX, United Kingdom
Related Publications (1)
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.
PMID: 36207643DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Schraag
Golden Jubilee National Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 15, 2011
Study Start
January 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
August 14, 2017
Record last verified: 2017-08