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
  Purpose

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.


Condition
General Anaesthesia
Propofol
Target Controlled Infusion
Pharmacokinetics

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
General Anaesthesia
Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01549639

Locations
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
Investigators
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
  More Information

No publications provided

Responsible Party: Nicholas J Cowley, Lead investigator, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01549639     History of Changes
Other Study ID Numbers: rrk4342
Study First Received: March 2, 2012
Last Updated: July 18, 2012
Health Authority: United Kingdom: National Research Ethics Service (NRES)

Keywords provided by University Hospital Birmingham NHS Foundation Trust:
Propofol
Target controlled infusion
General anaesthesia

Additional relevant MeSH terms:
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 18, 2014