Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549639
• Other study ID #: rrk4342
• Status: Completed
• Phase: N/A
• First received: March 2, 2012
• Last updated: July 18, 2012
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Research Ethics Service (NRES)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• General Anaesthesia
• Pharmacokinetics
• Propofol
• Target Controlled Infusion

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias)		duration of anaesthesia (up to 24 hours)	No
Secondary	Median absolute percentage prediction error of estimated propofol concentration compared to measured concentrations (inaccuracy)		duration of anaesthesia (up to 24 hours)	No
Secondary	Change in median percentage prediction error(bias)for propofol levels measured beyond thirty minutes following proportional correction at thirty minutes		thirty minutes	No