Clinical Trials Directory

Trials / Completed

CompletedNCT01549639

Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

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

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
University Hospital Birmingham NHS Foundation Trust · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2012-01-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2012-03-09
Last updated
2012-07-19

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01549639. Inclusion in this directory is not an endorsement.