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

Phase 3

Completed

• Conditions: narcose; Anesthesia; narcosis; 10082206

• Registration Number: NL-OMON42664
• Lead Sponsor: PAION UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 27

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Successful sedation is defined as a Narcotrend index of 60 or less during at<br /><br>least 85% of the maintenance time and no rescue sedative medication<br /><br>administered. The maintenance starts at arrival at the operation theater and<br /><br>ends with the completion of the last skin suture. In clinics with no change in<br /><br>the location of the patient between induction and start of the surgery,<br /><br>maintenance starts when the anesthesiologist permits the surgical team to start<br /><br>the surgical procedure including preparation of the surgical site(s).<br /><br>The primary endpoint is an efficacy endpoint.</p><br>