Blood Propofol Measurement During Anaesthesia Using Propo... | NCT01549639

Studies
Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

NCT01549639

Sponsor

University Hospital Birmingham NHS Foundation Trust

Status

Completed

Last Update Posted

Jul 19, 2012Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

General Anaesthesia
Propofol
Target Controlled Infusion
Pharmacokinetics

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 2, 2012

First Submission Date that Met QC Criteria

Mar 6, 2012

First Posted Date

Mar 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2012

Last Update Posted Date

Jul 19, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicholas J Cowley, Lead investigator, University Hospital Birmingham NHS Foundation TrustPrincipal Investigator

Lead Sponsor

University Hospital Birmingham NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General Anaesthesia		Patients undergoing general anaesthesia using Marsh model target controlled infusion in effect site mode.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Median percentage prediction error of estimated propofol concentration compared to measured concentrations (Bias)		duration of anaesthesia (up to 24 hours)

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Birmingham NHS Foundation Trust		Birmingham	West Midlands	B15 2TH	United Kingdom