Effect site targeted patient-maintained sedation with propofol

AR Absalom*, FHM Engbers#, N Sutcliffe*, GNC Kenny*

*University Department of Anaesthesia, Glasgow Royal Infirmary, Glasgow, Scotland

#Department of Anesthesiology, Leiden University Medical Centre, Leiden, The Netherlands

Background: Early patient-controlled sedation systems administered boluses or continuous infusions of sedative drugs on patient demand [1,2]. More recently Kenny and colleagues have developed a patient-maintained sedation system based on a target-controlled infusion (TCI) of propofol [3]. With this system a demand by the patient increases the target blood concentration of propofol by a fixed amount. However, unless the lockout period is very long, the blood propofol concentration can get far ahead of the brain concentration. If this happens the brain concentration may continue rising after the patient has stopped pressing the button, and this may render the patient unresponsive or unconscious. A TCI system that targets the effect-site (brain) concentration may enhance safety by overcoming this problem.

Methods: We have studied the safety of such a system in 9 healthy adult volunteers. The Bispectral Index was measured and recorded continuously throughout the study period. Baseline physiologic measurements (heart rate, blood pressure, SaO2) were made before starting, and thereafter every 5 minutes. Subjects were asked to press the handset as often as they wished, with the aim of trying to render themselves unconscious. When the handset button is pressed the system increases the propofol target by 100mcg/ml. It administers a bolus of propofol to rapidly increase the blood concentration to a level above that of the desired brain concentration. This is followed by an infusion, but the system then allows the blood concentration to decrease until the brain and blood concentrations converge on the new target concentration. The lockout period is 60 seconds. Sedation score, BIS, and the target and estimated brain and blood concentrations were recorded every minute. Once the subject stopped using the handset the target was set to zero, and the subject observed until fully recovered.  

Results: Six male and 3 female subjects were enrolled. Verbal contact was maintained with all subjects throughout the study. The median brain concentration at which subjects stopped using the handset was 2.2mcg/ml (range 1.3 to 3.9mcg/ml). At this point the median BIS was 66 (range 53 to 80). No subject was able to render him/herself unconscious. Physiological variables were stable throughout. There were no episodes of oxygen de-saturation, no subjects required supplementary oxygen, and there were no adverse effects other than aching in the arm during rapid infusion of propofol. 

Conclusion: In the subjects we have studied, effect site targeted patient-maintained propofol sedation has provided effective sedation that was pleasant, free of serious adverse effects and safe.

References

1.     Rudkin G et al. Intra-operative patient-controlled sedation. Anaesthesia 1992; 47: 376-81.

2.     Osborne GA et al. Intra-operative patient-controlled sedation and patient attitude to control. Anaesthesia 1994; 49: 287-92.

3.     Irwin MG et al. Patient maintained propofol sedation. Assessment of a target-controlled infusion system. Anaesthesia 1997; 52: 525-30.