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Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

NCT ID: NCT01549639

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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General Anaesthesia Propofol Target Controlled Infusion Pharmacokinetics

Keywords

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Propofol Target controlled infusion General anaesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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General Anaesthesia

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Nicholas J Cowley

Lead investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicholas J Cowley, MRCP FRCA

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham NHS Foundation Trust

Thomas Clutton-Brock, FRCA FRCP

Role: STUDY_CHAIR

University Hospital Birmingham NHS Foundation Trust

Locations

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University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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rrk4342

Identifier Type: -

Identifier Source: org_study_id