E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. . |
|
E.1.1.1 | Medical condition in easily understood language |
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. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether the blood propofol levels differ appreciably from the predicted levels in children undergoing major spinal surgery during total intravenous anaesthesia. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The analysis of the data will be descriptive |
|
E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The analsysis of the data will be descriptive |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of trial is defined as 6 months after the last patient participates in the study. This is to allow for data collection
and writingup,
before archiving as per regulations. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |