SummaryPrevious volunteer studies of an effect-site controlled patient-maintained sedation system using propofol have demonstrated a risk of oversedation. We have incorporated a reaction time monitor into the handset to add an individualised patient-feedback mechanism. This pilot study assessed if the reaction time-feedback modification would prove safe and effective in 20 healthy patients receiving sedation while undergoing oral surgery. All patients successfully sedated themselves without reaching any unsafe endpoints. All 20 maintained verbal contact throughout. The mean (SD) lowest peripheral blood oxygen saturation was 98.0 (2.1)% breathing room air. No patient required supplementary oxygen. The mean (SD) maximum effect-site propofol concentration reached was 1.6 (0.5) lg.ml
À1. The present system was found to be safe and effective, allowing oral surgery treatment under conscious sedation, but preventing oversedation. Effect-site controlled, patient-maintained sedation with propofol allows the patient to control target controlled infusions of propofol, and hence his/her level of sedation, using a hand-held demand button. The system sets a target effect-site concentration [1] at a low level initially, which can be increased incrementally by the patient pressing the handset button twice within 1 s. The system increases the plasma concentration up to 100% greater than the target effect-site concentration to 'force' the drug rapidly into the effect site, and then reduces the plasma concentration as the target effect-site concentration is approached. Instead of a traditional time-based lockout, the patient is not able to obtain a further increment until the plasma concentration decreases to within 10% of the target effect-site concentration -an 'effect-site lockout'. As the brain is the site of action of propofol, this allows for equilibration between the blood and brain. This technique was found by our group to be safe and effective in patients having dental surgery [2], but the potential for oversedation was demonstrated in volunteers who were instructed to try deliberately to oversedate themselves [3][4][5].