A closed-loop system for propofol administration using the BIS as a controlled variable together with a model-based controller is clinically acceptable during general anesthesia.

Effect compartment-controlled TCI can be safely applied in clinical practice. A biophase model combining the Marsh kinetics and a time to peak effect of 1.6 min accurately predicted the time course of propofol drug effect.

SummaryTen patients, undergoing elective orthopaedic surgery under spinal anaesthesia, were sedated with propofol using a closed-loop feedback control system. The bispectral index (BIS), a new processed EEG parameter, was used as control variable. Propofol administration was controlled by a patient individualised adaptive model-based controller incorporating target-controlled infusion technology combined with a pharmacokinetic-dynamic model. This feedback control system for propofol administration proved to be adequate and safe. BIS was found to be well suited as control variable.

Sixty unpremedicated patients (30 male) were randomly allocated to three groups. They received an induction dose of propofol 2 mg kg-1 over 5, 20 or 60 s to a forearm vein. Anaesthesia was maintained with conventional inhalation anaesthetic agents. Anaesthesia was induced satisfactorily in all 20 of the patients in the 5-s group, in 19 of the patients in the 20-s group and in 18 of the patients in the 60-s group. The rate of injection had a significant influence on induction time. Mean induction time increased from 21.5 to 34.7 and 50.5 s, when injection time was increased from 5 to 20 to 60 s, respectively. Similar induction times were found in male and female patients. There was no significant difference between the groups, in depth of anaesthesia obtained--as assessed by the eyelash reflex. Mean arterial pressure decreased to the same extent in all three groups. Two minutes after induction, mean systolic arterial pressure was reduced by 15.1, 13.5 and 19.3 mm Hg in the 5-, 20- and 60-s groups, respectively, and mean diastolic arterial pressure by 10.3, 13.2 and 13.7 mm Hg. Heart rate changes were insignificant. Apnoea of more than 10 s duration was seen frequently in all three groups, but the results suggest that the incidence was not influenced by the rate of injection. Three patients experienced mild pain at the time of injection. No major adverse reactions occurred during or after anaesthesia.

The bispectral index, a new processed electroencephalographic parameter which may give information on depth of anaesthesia, was used in 58 patients undergoing outpatient gynaecological surgery in order to study if the addition of bispectral index monitoring to standard clinical monitoring could improve the titration of target propofol concentration when using effect-site target-controlled propofol infusion for sedation. In Group 1 (n = 30), the bispectral index was recorded but the anaesthetist was unaware of the readings and therefore only classical signs of depth of anaesthesia were used to guide the anaesthetist in controlling the effect-site concentration. In Group 2 (n = 28), bispectral index readings were available to the anaesthetist and effect-site concentration was adjusted to ensure that bispectral index was maintained between 40 and 60. Similar propofol induction and maintenance doses, blood and effect-site concentrations and mean bispectral index were found in the two groups. A greater percentage of bispectral index readings lying outside the target range (i.e. < 40 or > 60) and more movement at incision and during maintenance were found in Group 1. There was a trend towards more implicit awareness in patients in Group 1. Bispectral index was found to be useful for measuring depth of sedation when using propofol target-controlled infusion. Propofol dosage could not be decreased but a more consistent level of sedation could be maintained due to a more satisfactory titration of target effect-site concentration.