Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion
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| First Received Date ICMJE | March 2, 2012 | ||||||||
| Last Updated Date | July 18, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01549639 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients treated in the Operating Theatre undergoing propofol intravenous anaesthesia who require an arterial line to be inserted as standard care. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | General Anaesthesia
Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | June 2012 | ||||||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01549639 | ||||||||
| Other Study ID Numbers ICMJE | rrk4342 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Nicholas J Cowley, University Hospital Birmingham NHS Foundation Trust | ||||||||
| Study Sponsor ICMJE | University Hospital Birmingham NHS Foundation Trust | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Birmingham NHS Foundation Trust | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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