Effect of ciprofol on left ventricular myocardial strain and myocardial work in children undergoing open-heart surgery: a single-center double-blind randomized non-inferiority study

Objective To compare the effect of ciprofol and propofol on left ventricular (LV) systolic function and myocardial work by noninvasive speckle-tracking echocardiography (STE) in children undergoing surgical repair of atrial septal defect (ASD) or ventricular septal defect (VSD). Design Single-center double-blind randomized non-inferiority study. Setting At a tertiary care center affiliated to Shanghai Jiao Tong University, China. Participants One hundred and twelve children aged 1 month to 16 years old undergoing ASD or VSD surgery with cardiopulmonary bypass. Interventions One hundred and twelve children were allocated randomly into receiving ciprofol (n = 67) and propofol (n = 45) in a 1.5:1 ratio. Ciprofol or propofol were IV infused at loading doses of 0.4 mg/kg or 2.0 mg/kg respectively over 30 seconds depending on the physical condition of each patient. When the bispectral index was maintained between 45 - 55 after induction, transthoracic echocardiography including apical two-chamber, three-chamber and four-chamber views were collected at bedside. Measurements and Main Results Of total 112 patients enrolled, 104 completed the study. The global longitudinal strain (GLS) of ciprofol and propofol groups after anesthesia was -17.3% (95% CI, -18.0% to -16.6%) and -17.8% (-18.7 to -17.0%) in the full analysis set (FAS) and -17.5% (95% CI, -18.2% to -16.9%) and -17.8% (-18.7% to -17.0%) in the per-protocol set (PPS) respectively. The noninferiority margin was set as 2% and confirmed with a lower limit of two-sided 95% CI for the inter-group difference of 1.58% and 1.34% in the FAS and PPS. There were no significant differences between two groups in LV systolic and diastolic function and myocardial work indices. Postoperative vasoactive-inotropic score, NT-proBNP, duration of mechanical ventilation, length of stay in cardiac intensive care unit and hospital were also comparable between two groups (all p > 0.05). Conclusions Ciprofol did not show different effect from propofol on myocardial function and postoperative outcomes. Furtherly on sensitive cardiac systole marker GLS, ciprofol had noninferiority to propofol. Ciprofol might be alternative solution for cardiac anesthesia in CHD children with mild lesion.