A Randomized, Single-blind, Propofol-controlled Phase III Study Evaluating the Efficacy and Safety of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, including Follow-up Sedation in the Post-anesthesia Care Unit / Intensive Care Unit - CNS7056-011

PAION UK Limited0 个研究点目标入组 27 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* Patients scheduled for major non-emergency cardiac surgery assumed to require more than 2 hours of maintenance of general anesthesia and to require the use of extracorporeal circulation, including coronary bypass(es), valve replacement(s) and associated procedures and on-pump minimal invasive surgery
•* Scheduled to receive mechanical ventilation via tracheal intubation (oropharyngeal or nasotracheal)
•* Age at least 18 years
•* Body Mass Index (BMI) 18 to * 40 kg/m2

•* Re-do cardiac surgery
•* Surgical procedures that comprise the use of drugs and/or devices that are not approved for marketing
•* Severe tricuspidal insufficiency
•* Planned cooling below 32ºC
•* History of or planned stop of circulation, e.g. due to repair of type A dissection of aorta or removal of thrombi from pulmonary artery
•* Planned to receive epidural/spinal anesthesia together with general anesthesia
•* Evidence of uncontrolled hepatic, central nervous system, respiratory, or metabolic dysfunction, or other clinically significant findings at screening that, in the investigator*s or medical monitor*s opinion, should exclude them from the study.
•* Poorly controlled hypertension (e.g. systolic blood pressure *160 mmHg under antihypertensive medication at screening)
•* Severe renal insufficiency or end-stage renal disease (creatinine clearance below 30 mL/min or estimated glomerular filtration rate below 30 mL/min/1.73 m2).
•* Clinically uncontrolled coagulation abnormalities, or coagulation abnormalities not under adequate treatment
•* Scheduled for heart or lung transplantation
•* Infectious cardiac disorders (e.g. endocarditis, myocarditis)
•* Emergency surgery, status of shock or coma
•* Ejection fraction from left ventricle of less than 20%
•* Acute right heart failure

发起方