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Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

Sponsor
University Hospital Birmingham NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01549639
Collaborator
(none)
50
Enrollment
1
Location
5
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    General Anaesthesia

    Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode.

    Outcome Measures

    Primary Outcome Measures

    1. Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias) [duration of anaesthesia (up to 24 hours)]

    Secondary Outcome Measures

    1. Median absolute percentage prediction error of estimated propofol concentration compared to measured concentrations (inaccuracy) [duration of anaesthesia (up to 24 hours)]

    2. Change in median percentage prediction error(bias)for propofol levels measured beyond thirty minutes following proportional correction at thirty minutes [thirty minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • Anaemic patients will not be recruited into the study.

    • Patients unable to consent will not be recruited into the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Birmingham NHS Foundation Trust Birmingham West Midlands United Kingdom B15 2TH

    Sponsors and Collaborators

    • University Hospital Birmingham NHS Foundation Trust

    Investigators

    • Principal Investigator: Nicholas J Cowley, MRCP FRCA, University Hospital Birmingham NHS Foundation Trust
    • Study Chair: Thomas Clutton-Brock, FRCA FRCP, University Hospital Birmingham NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicholas J Cowley, Lead investigator, University Hospital Birmingham NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT01549639
    Other Study ID Numbers:
    • rrk4342
    First Posted:
    Mar 9, 2012
    Last Update Posted:
    Jul 19, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Nicholas J Cowley, Lead investigator, University Hospital Birmingham NHS Foundation Trust
    Propofol
    Target controlled infusion
    General anaesthesia

    Study Results

    No Results Posted as of Jul 19, 2012