Clinical trial NCT01932424: Blood Propofol Concentrations in Children During Spinal Surgery
Official title: Comparison of Measured Versus Predicted Blood Propofol Concentrations During Total Intravenous Anaesthesia in Children Undergoing Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spine Deformities
Idiopathic Scoliosis
Neuromuscular Dystrophy
Keywords: Children
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: The absolute difference between the measured and predicted concentrations of propofol in micrograms per ml of blood.
timeFrame: 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:
measure: Median Performance Error (MDPE)
timeFrame: Up to 5 hours during the maintenance phase of anaesthesia, to allow a maximum of 10 samples at 20 to 30 min intervals.
measure: Median Absolute Performance Error (MDAPE)
timeFrame: Up to 5 hours during the maintenance phase of anaesthesia
measure: Wobble
timeFrame: Up to 5 hours during the maintenance phase of anaesthesia
measure: Divergence
timeFrame: Up to 5 hours during the maintenance phase of anaesthesia
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS trust
Study officials:
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Michael RJ Sury, FRCA PhD
role: STUDY_DIRECTOR
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Selvakumar Panchatsharam, MBBS FRCA
role: PRINCIPAL_INVESTIGATOR
References: