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Blood Propofol Concentrations in Children During Spinal Surgery

NCT ID: NCT01932424

Last Updated: 2013-08-30

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

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

Brief Summary

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During major spinal surgery evoked potential monitoring is performed to detect spinal cord damage. Intra-venous anaesthesia is the preferred anaesthetic technique because volatile anaesthetic agents supress the evoked potentials. Total Intra-Venous Anaesthesia (TIVA) with propofol is commonly administered as a Target Controlled Infusion (TCI). The TCI is an automated drug delivery system which administers propofol to achieve a desired blood concentration, based on an in built pharmaco-kinetic data (TCI model) derived from previous studies. The TCI model also provides a real time predicted blood concentration to facilitate the anaesthetist to adjust the target concentration of propofol.

The TCI algorithm is based on pharmaco-kinetic data derived from previous studies in a relatively small number of patients, by a "best fit" relationship between blood levels, infusion rates and other factors (such as age and weight). Several factors make it possible for a wide discrepancy between the predicted and the true blood concentrations. This difference can be higher in children compared to adults. Also blood loss and administration of large volumes of intravenous fluids can affect the blood concentrations. This study aims to identify the difference between the predicted and true blood concentrations by using Pelorus 1500, a bedside blood propofol measurement device, in children undergoing major spinal surgery under TIVA.

Detailed Description

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Conditions

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Spine Deformities Idiopathic Scoliosis Neuromuscular Dystrophy

Keywords

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Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Single arm

The intervention in this study involves taking blood sample from an existing arterial line for measurement of blood propofol levels. The drug in evaluation is Propofol 2% (Diprivan 2%, Astra Zeneca UK) administered as a target controlled infusion using the commercially available paediatric TCI models (Paedfusor and Marsh models). The dose range is usually between a target concentration of 3-8 mcg/ml. However the anaesthetic management is not changed for the study. The blood concentrations of propofol will be measured using Pelorus 1500 (Sphere Medical, UK), a CE marked device. The anaesthetist will be blinded from the measurements, unless the measured value was outside the safe limit ( \< 3 mcg/ml or \> 10mcg/ml).

Group Type EXPERIMENTAL

Pelorus 1500

Intervention Type DEVICE

a bedside blood propofol measurement device

Propofol 2% (Diprivan 2%, Astra Zeneca UK)

Intervention Type DRUG

Interventions

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Pelorus 1500

a bedside blood propofol measurement device

Intervention Type DEVICE

Propofol 2% (Diprivan 2%, Astra Zeneca UK)

Intervention Type DRUG

Other Intervention Names

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Sphere Medical, UK

Eligibility Criteria

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Inclusion Criteria

* Children undergoing major spinal surgery under propofol TCI
* Surgery expecting to last more than 3 hours.

Exclusion Criteria

* Major hepatic or renal disease
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael RJ Sury, FRCA PhD

Role: STUDY_DIRECTOR

Great Ormond Street Hospital for Children NHS Foundation Trust

Selvakumar Panchatsharam, MBBS FRCA

Role: PRINCIPAL_INVESTIGATOR

Great Ormond Street Hospital for Children NHS Foundation Trust

Locations

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Great Ormond Street Hospital for Children NHS trust

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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12AR04

Identifier Type: -

Identifier Source: org_study_id