Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion
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Purpose
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 |
|---|
|
General Anaesthesia Propofol Target Controlled Infusion Pharmacokinetics |
| Study Type: | Observational |
| Study Design: | 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 |
- Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias) [ Time Frame: duration of anaesthesia (up to 24 hours) ] [ Designated as safety issue: No ]
- Median absolute percentage prediction error of estimated propofol concentration compared to measured concentrations (inaccuracy) [ Time Frame: duration of anaesthesia (up to 24 hours) ] [ Designated as safety issue: No ]
- Change in median percentage prediction error(bias)for propofol levels measured beyond thirty minutes following proportional correction at thirty minutes [ Time Frame: thirty minutes ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | January 2012 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
General Anaesthesia
Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode.
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients treated in the Operating Theatre undergoing propofol intravenous anaesthesia who require an arterial line to be inserted as standard care.
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| United Kingdom | |
| University Hospitals Birmingham NHS Foundation Trust | |
| Birmingham, West Midlands, United Kingdom, B15 2TH | |
| 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 |
More Information
No publications provided
| Responsible Party: | Nicholas J Cowley, Lead investigator, University Hospital Birmingham NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01549639 History of Changes |
| Other Study ID Numbers: | rrk4342 |
| Study First Received: | March 2, 2012 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United Kingdom: National Research Ethics Service (NRES) |
Keywords provided by University Hospital Birmingham NHS Foundation Trust:
|
Propofol Target controlled infusion General anaesthesia |
Additional relevant MeSH terms:
|
Anesthetics Propofol Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 23, 2013