Anesthesia in adult patients undergoing cardiac surgery. MedDRA version: 18.1 Level: LLT Classification code 10021722 Term: Induction and maintenance anaesthesia System Organ Class: 100000004865
Conditions
Interventions
Product Name: Remimazolam
Product Code: CNS7056
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Remimazolam besylate
CAS Number: 1001415-66-2
Current Sponsor code: CNS
Sponsors
PAION UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show non-inferiority of remimazolam compared with propofol in terms of successful maintenance of sedation during general anesthesia defined as Narcotrend index of 60 or less during at least 85% of the maintenance time without the use of rescue sedative medication.;Timepoint(s) of evaluation of this end point: Phase of general anesthesia (Day 1).;Secondary Objective: •to show superiority of remimazolam compared with propofol in terms of haemodynamic stability •to assess the efficacy of remimazolam compared with propofol •to assess the safety of remimazolam compared with propofol •to assess quality of life •to investigate pharmacokinetics in patients exposed for more than 24 hours • to collect data potentially relevant for pharmacoeconomics;Primary end point(s): Successful sedation is defined as a Narcotrend index of 60 or less during at least 85% of the maintenance time and no rescue sedative medication administered. The maintenance starts at arrival at the operation theater and ends with the completion of the last skin suture. In clinics with no change in the location of the patient between induction and start of the surgery, maintenance starts when the anesthesiologist permits the surgical team to start the surgical procedure including preparation of the surgical site(s). The primary endpoint is an efficacy endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Phase of general anesthesia (Day 1). ;Secondary end point(s): The haemodynamic stability is expressed in terms of the amount of norepinephrine actually administered per body weight and time between start of the study medication (remimazolam or propofol) for induction of the general anesthesia and the completion of the last skin suture. A lower amount of norepinephrine actually administered corresponds to a higher hemodynamic stability. The key secondary endpoint is a safety endpoint. | — |
Countries
Belgium, France, Germany, Netherlands, Poland, Switzerland
Contacts
Public ContactClinical trial information
PAION Deutschland GmbH
Outcome results
None listed