Evaluation of propofol TCI anaesthesia in infants age 6m-3y v1.0

• Research type

  Research Study

• Full title

  Evaluation of propofol target-controlled infusion anaesthesia in infants age 6 months-3 years

• IRAS ID

  5518

• Contact name

• Sponsor organisation

  NHS Greater Glasgow and Clyde

• Eudract number

  2008-005086-55

• ISRCTN Number

  ISRCTN00098907

• Research summary

  Propofol is the most commonlyused intravenous anaesthetic agent in adults and children. When used with acomputer-controlled syringe infusion pump, propofol can be given precisely toachieve a target concentration in the blood and in the brain. This determinesthe level of anaesthesia. The accuracy of the computer software package (calledPaedfusor) in the pump has been checked for children above age 3 years andperforms very well but this study is in children aged 6 months to 3 years. 50healthy children weighing from 7-16kg will be studied. These children areattending a specialist children's hospital for planned surgery under generalanaesthesia lasting 30 minutes or more. To check the accuracy of the propofoldelivered by the Paedfusor system, blood samples from a cannula in a vein willbe taken to measure the concentration of propofol. From the concentration ofpropofol calculated by the pump and the concentration measured in the blood,four standard measures are then calculated namely bias, precision, divergenceand wobble. These assess whether thesystem over- or under-delivers propofol, by how much and how this variesbetween children and for an individual child over time. The blood concentrationmeasurements can also be used to calculate how younger children handle propofolin terms of its movement around the body, and how it is broken down and removedfrom the body. This information may also reveal any effects of age, weight andgender. The results will help to improve the accuracy of propofol delivery toyounger children for anaesthesia. The costs of the propofol measurements inblood are being met by Alaris Cardinal Health.

• REC name

  West of Scotland REC 4

• REC reference

  08/S0709/110

• Date of REC Opinion

  18 Nov 2008

• REC opinion

  Further Information Favourable Opinion