Blood Propofol Concentrations in Children During Spinal Surgery
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust