Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial

Abstract

To compare automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration of short-acting drugs in critical care patients requiring deep sedation. The primary outcome was the percentage of BIS values between 40 and 60 (BIS(40-60)). This randomized controlled phase II trial in the intensive care unit (ICU) was conducted in adults with multiorgan failure. Thirty-one patients were assigned to receive sedation with propofol or remifentanil either by an automated or a manual system, both targeting BIS(40-60). Performance and feasibility of an automated administration were assessed. The study groups were well balanced in terms of demographic characteristics. Study duration averaged 18 [8-24] h in the automated group and 14 [9-21] h in the manual group (p = 0.81). Adequate sedation (BIS(40-60)) was significantly more frequent in the automated group 77 [59-82] % than in the manual group 36 [22-56] %, with p = 0.001. Propofol consumption was reduced by a factor of 2 in the automated group with a median change of infusion rates of 39 ± 9 times per hour. In contrast, there were only 2 ± 1 propofol and 1 ± 1 remifentanil dose changes per hour in the manual group compared to 40 ± 9 for remifentanil in the automated group (p < 0.001). Vasopressors were more often discontinued or reduced in the automated group than in the manual control group (36 [6-40] vs. 12 [4-20] modifications, p = 0.03). Continuous titration of propofol and remifentanil sedation with an automatic controller maintains deep sedation better than manual control in severely ill patients. It is associated with reduced sedative and vasopressor use.