Effect-sites of intravenous anaesthetic agents
K. Morita, T. Kazama. Surgical Center, Hospital of Hamamatsu University, and the Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine, Japan

Effect-site
One of the aims of target-controlled infusion (TCI) is to control the pharmacological effects as adequately as the anesthesiologist would like. The concentration in plasma or in blood had been thought to be the target object for a long time after TCI had been developed. However the pharmacological effect, such as the hypnotic one of propofol, might be delayed for a short while compared to that estimated by the plasma concentration just after the plateau is reached. This is the fact we have experienced every day clinically. In some anesthetics, their pharmacological effects can be monitored by the EEG analysis. Stanski et. al. showed the hysteresis trajectory could be seen when plotting the EEG response against the plasma concentration on onset period and that on recovery period. This phenomenon can be explained by the existence of the first-order time delay between plasma concentration and its effect. The hypothetical effect-site was introduced to incorporate this delay on time domain into the disposition kinetic modeling and that is related to the phase equilibration between plasma and effect-site and so that it called bio-phase occasionally. The effect-site can be characterized only by the rate constant from effect-site to outside of the body (keo) and not by rate constant from central compartment to the effect-site nor by volume of effect-site because the hypothetical effect-site has the negligible small compartment in which net mass transfer from central to effect can not be accounted. The keo can be defined that the reciprocal of the time required decreasing the response to -63.2 % of initial value and has dimension of min-1. The t1/2keo is a response time to decrease half of initial value, and equals 0.693/keo(min)

Keo
The anesthetics have different pharmacological effects and each effect consists of different keo. For example, the keo(min-1) of fentanyl has been reported as 0.105 (min-1) by Scott JC et.al. and that of propofol was reported as 0.239 (min-1) by Shuttler J et. al. The keo of fentanyl is about half that of propofol, which means twice longer time required in the fentanyl to equilibrate plasma concentration and the effect. As well as the different anesthetics have its own keo, even in the same anesthetic there are some different keos consisted in different pharmacological effects. Propofol has a hypnotic effect mainly but has a hemodynamic effect subsidiary. The keo for them are different. We have recently studied propofol keo for hypnosis by measuring bi-spectral index (BIS), and keo for hemodynamic effect by measuring the response of the systolic blood pressure (SBP) against the concentration of propofol. They were estimated as 0.300 (min-1) for BIS response and 0.118 (min-1) for systolic pressure response in the patient group aged 20 to 39 years (P<0.05). The equilibration time between plasma and the effect-site, which is related with controlling the systolic pressure, was three times longer than that related with controlling the hypnosis.

Do these keos have dependency of the age of the patients? The keo for BIS did not have a significant difference between the group aged 20-39 and that of 70-85, however in keo for SBP had significant difference between these groups, 0.118 and 0.0678 respectively (p< 0.05).

Simulation
In usual clinical practice, suppose that we set the TCI target concentration as 10mg/ml with fentanyl background (2ng/ml), we might simulate that the intubation could be possible most adequately after when 6.93min (3 times of t1/2keo (=87.5% response time) of hypnotic) had passed from the plasma plateau had reached. The t1/2keo for systolic blood pressure is 5.68 (min), then at the time of intubation (estimated above) the blood pressure supposed to be decreased about -55% of maximal amplitude of depression.

The dosing scheme and concentration time-course can be estimated by solving the pharmacokinetics compartment model and applying the concentration-effects relationship (pharamcodynamics) to this derived concentration time-course, we can estimate the pharmacological effects. However without the keo, which is a constant represented interrelation on time domain between Dconcentration and Deffects, the sudden change of concentration will make sudden change of effects and that response is far apart from the real response seen in clinical situations.

Automated control of the effects
The hypnotic index BIS can be used to the input signal of the feedback source of the TCI system, and that might control hypnotic response as constant as anesthesiologist requested. In its algorithm a time response function expressed by the keo against unit-step input function was consisted and may decrease the chance of becoming unstable oscillating state.