OBJECTIVE: The objective of this study was to compare the feasibility of closed-loop anesthesia delivery with manual control of propofol in pediatric patients during cardiac surgery. METHODS:Forty ASA II-III children, undergoing elective cardiac surgery under cardiopulmonary bypass (CPB) in a tertiary care hospital, were randomized to receive propofol either through a closed-loop anesthesia delivery system (CL group) or through traditional manual control (manual group) to achieve a target BIS of 50. Patients were induced and subsequently maintained with a propofol infusion. The propofol usage and the efficacy of closed-loop system in controlling BIS within ±10 of the target were compared with that of manual control. RESULTS: The maintenance of BIS within ±10 of target and intraoperative hemodynamic stability were similar between the two groups. However, induction dose of propofol was less in the CL group (2.06 ± 0.79 mg·kg(-1) ) than the manual group (2.95 ± 1.03 mg·kg(-1) ) (P = 0.006) with less overshoot of BIS during induction in the closed-loop group (P = 0.007). Total propofol used in the off-CPB period was less in the CL group (6.29 ± 2.48 mg·kg(-1) h(-1) vs 7.82 ± 2.1 mg·kg(-1) h(-1) ) (P = 0.037). Phenylephrine use in the pre-CPB period was more in the manual group (16.92 ± 10.92 μg·kg(-1) vs 5.79 ± 5.98 μg·kg(-1) ) (P = 0.014). Manual group required a median of 18 (range 8-29) dose adjustments per hour, while the CL group required none. CONCLUSION: This study demonstrated the feasibility of closed-loop controlled propofol anesthesia in children, even in challenging procedures such as cardiac surgery. Closed-loop system needs further and larger evaluation to establish its safety and efficacy.
RCT Entities:
OBJECTIVE: The objective of this study was to compare the feasibility of closed-loop anesthesia delivery with manual control of propofol in pediatric patients during cardiac surgery. METHODS: Forty ASA II-III children, undergoing elective cardiac surgery under cardiopulmonary bypass (CPB) in a tertiary care hospital, were randomized to receive propofol either through a closed-loop anesthesia delivery system (CL group) or through traditional manual control (manual group) to achieve a target BIS of 50. Patients were induced and subsequently maintained with a propofol infusion. The propofol usage and the efficacy of closed-loop system in controlling BIS within ±10 of the target were compared with that of manual control. RESULTS: The maintenance of BIS within ±10 of target and intraoperative hemodynamic stability were similar between the two groups. However, induction dose of propofol was less in the CL group (2.06 ± 0.79 mg·kg(-1) ) than the manual group (2.95 ± 1.03 mg·kg(-1) ) (P = 0.006) with less overshoot of BIS during induction in the closed-loop group (P = 0.007). Total propofol used in the off-CPB period was less in the CL group (6.29 ± 2.48 mg·kg(-1) h(-1) vs 7.82 ± 2.1 mg·kg(-1) h(-1) ) (P = 0.037). Phenylephrine use in the pre-CPB period was more in the manual group (16.92 ± 10.92 μg·kg(-1) vs 5.79 ± 5.98 μg·kg(-1) ) (P = 0.014). Manual group required a median of 18 (range 8-29) dose adjustments per hour, while the CL group required none. CONCLUSION: This study demonstrated the feasibility of closed-loop controlled propofol anesthesia in children, even in challenging procedures such as cardiac surgery. Closed-loop system needs further and larger evaluation to establish its safety and efficacy.