Patient‐maintained propofol sedation using reaction time monitoring: a volunteer safety study

Summary Previous volunteer studies of an effect‐site controlled, patient‐maintained sedation system using propofol have demonstrated a risk of over‐sedation. We have incorporated a reaction‐time monitor into the handset of the patient‐maintained sedation system to add an individualised patient‐feedback mechanism. This study assessed if such reaction‐time feedback modification would reduce the risk of over‐sedation in 20 healthy volunteers deliberately attempting to over‐administer themselves propofol. All the volunteers successfully sedated themselves without reaching any unsafe endpoints. All volunteers maintained verbal contact throughout, in accordance with the definition of conscious sedation. The mean (SD) lowest SpO2 was 97 (1.7) % when breathing room air and no volunteer required supplementary oxygen. The mean (SD) maximum effect‐site propofol concentration reached was 1.7 (0.4) μg.ml−1. The present system was found to be safer than its predecessors, allowing conscious sedation, but preventing over‐sedation.