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

PAION UK Limited0 个研究点目标入组 530 人开始时间: 2015年9月28日最近更新: 2016年4月11日

试验速览

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•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 265
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 265

•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