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Blood Propofol Concentrations in Children During Spinal Surgery

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ClinicalTrials.gov Identifier: NCT01932424
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Spine Deformities Idiopathic Scoliosis Neuromuscular Dystrophy Device: Pelorus 1500 Drug: Propofol 2% (Diprivan 2%, Astra Zeneca UK) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Official Title: Comparison of Measured Versus Predicted Blood Propofol Concentrations During Total Intravenous Anaesthesia in Children Undergoing Spinal Surgery
Study Start Date : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: 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).
Device: Pelorus 1500
a bedside blood propofol measurement device
Other Name: Sphere Medical, UK

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932424


Locations
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United Kingdom
Great Ormond Street Hospital for Children NHS trust
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
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Study Director: Michael RJ Sury, FRCA PhD Great Ormond Street Hospital for Children NHS Foundation Trust
Principal Investigator: Selvakumar Panchatsharam, MBBS FRCA Great Ormond Street Hospital for Children NHS Foundation Trust

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01932424     History of Changes
Other Study ID Numbers: 12AR04
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
Children
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics