Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicholas J Cowley, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01549639
First received: March 2, 2012
Last updated: July 18, 2012
Last verified: July 2012

March 2, 2012
July 18, 2012
January 2012
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01549639 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients treated in the Operating Theatre undergoing propofol intravenous anaesthesia who require an arterial line to be inserted as standard care.

  • General Anaesthesia
  • Propofol
  • Target Controlled Infusion
  • Pharmacokinetics
Not Provided
General Anaesthesia
Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01549639
rrk4342
No
Nicholas J Cowley, University Hospital Birmingham NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Not Provided
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
University Hospital Birmingham NHS Foundation Trust
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP