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Completed

NCT Number: NCT01932424

Blood Propofol Concentrations in Children During Spinal Surgery

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Great Ormond Street Hospital for Children NHS trust

London, WC1N 3JH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelorus 1500

Device

a bedside blood propofol measurement device

Other names: Sphere Medical, UK

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

Drug

Primary outcomes

  1. The absolute difference between the measured and predicted concentrations of propofol in micrograms per ml of blood.

    Time frame: Up to 5 hours during the maintenance phase of anaesthesia, to allow a maximum of 10 samples at 20 to 30 min intervals.

Secondary outcomes

  1. Median Performance Error (MDPE)

    Time frame: Up to 5 hours during the maintenance phase of anaesthesia, to allow a maximum of 10 samples at 20 to 30 min intervals.

    The median value of ratio between the measured and predicted concentration of propofol to the predicted concentration (Performance error) in blood. Expressed as a percentage. This is a measure of overall bias of the target controlled infusion.

  2. Median Absolute Performance Error (MDAPE)

    Time frame: Up to 5 hours during the maintenance phase of anaesthesia

    The median value of the ratio of the absolute difference (excluding the sign) between the measured and predicted concentrations to the predicted concentration (Absolute performance error) in blood. Expressed as percentage. This is a measure of the accuracy of the target controlled infusion.

  3. Wobble

    Time frame: Up to 5 hours during the maintenance phase of anaesthesia

    The median value of the difference between the individual performance errors and the Median Performance Error (MDPE). This is a measure of the distribution of the performance errors around the median.

  4. Divergence

    Time frame: Up to 5 hours during the maintenance phase of anaesthesia

    The median of the regression coefficient of the performance error against time. This is a measure of how the target controlled infusion performs with time.

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Registry information

Official study title

Comparison of Measured Versus Predicted Blood Propofol Concentrations During Total Intravenous Anaesthesia in Children Undergoing Spinal Surgery

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2013
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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