Children undergoing spinal surgery have propofol anaesthesia delivered by a computerised syringe driver (Target Controlled Infusion or TCI). Spinal surgery is associated with major blood loss. This can result in either over or under-delivery of propofol, both can result in serious problems during anaesthesia. .
Conditions
Interventions
Trade Name: Diprivan 2%
Pharmaceutical Form: Emulsion for injection/infusion
INN or Proposed INN: PROPOFOL
CAS Number: 2078-54-8
Concentration unit: % percent
Concentration type: equal
Concentration n
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients included (All of the below): 1. Children between the age of 5 and 18 years 2. Undergoing spinal surgery lasting more than 3 hours 3. Receiving Propofol intravenous anaesthesia as the primary anaesthetic. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients excluded (Either of the below) 1. Surgery expecting to last less than 3 hours 2. Patients with major hepatic or renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the blood propofol levels differ appreciably from the predicted levels in children undergoing major spinal surgery during total intravenous anaesthesia.;Secondary Objective: To evaluate the effect of blood loss on the difference between the measured and predicted blood levels. To determine the potential value of a bedside blood propofol measurement.;Primary end point(s): The difference between the predicted and measured blood levels of propofol during the maintenance stage of anaesthesia. The difference is calculated as a proportion to the predicted blood level – and is termed Prediction or Performance Error (PE) PE = (Cm – Cp / Cp) * 100%; Cm = Measured Concentration, Cp = Predicted concentration.;Timepoint(s) of evaluation of this end point: The analysis of the data will be descriptive | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Median prediction error (MDPE) • a descriptor of the centre of the distribution of PE • known as “bias” Median absolute prediction error (MDAPE) • Median | PE | • A descriptor of the variation in PE Wobble • PE-MDPE • A descriptor of variation of PE around bias Drift • Regression coefficient of PE v time;Timepoint(s) of evaluation of this end point: The analsysis of the data will be descriptive | — |
Countries
United Kingdom
Contacts
Public ContactJoint R&D office
Great Ormond Street Hospital
Outcome results
None listed