Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

NCT01549639 | Completed

• 1 other identifier: rrk4342
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anaesthesia; Propofol; Target Controlled Infusion; Pharmacokinetics

Keywords

Propofol; Target controlled infusion; General anaesthesia

Outcome Measures

Primary Outcomes (1)

• Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias)

  duration of anaesthesia (up to 24 hours)

Secondary Outcomes (2)

• Median absolute percentage prediction error of estimated propofol concentration compared to measured concentrations (inaccuracy)

  duration of anaesthesia (up to 24 hours)

• Change in median percentage prediction error(bias)for propofol levels measured beyond thirty minutes following proportional correction at thirty minutes

  thirty minutes

Study Arms (1)

General Anaesthesia

Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Anaemic patients will not be recruited into the study.
• Patients unable to consent will not be recruited into the study.

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Study Officials

• Nicholas J Cowley, MRCP FRCA

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Thomas Clutton-Brock, FRCA FRCP

  University Hospital Birmingham NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead investigator

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 9, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

GB (1)