Clinical phase III study of the sedative remimazolam in general narcosis in adult patients undergoing heart surgery, including subsequent care in the post-anesthesia/intensive care unit, in order to evaluate the effects and safety of remimazolam.

Phase 1

Conditions: Anesthesia in adult patients undergoing cardiac surgery.
MedDRA version: 18.1Level: LLTClassification code 10021722Term: Induction and maintenance anaesthesiaSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-004565-24-DE

Lead Sponsor: PAION UK Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 530

Inclusion Criteria

•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

Exclusion Criteria

•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)
•Sepsis
•Emergency surgery, status of shock or coma
•Ejection fraction from left ventricle of less than 20%
•Acute right heart failure