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Clinical Trials/NL-OMON42664
NL-OMON42664
Completed
Phase 3

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 sites27 target enrollmentTBD
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ConditionsnarcoseAnesthesianarcosis10082206

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
narcose
Sponsor
PAION UK Limited
Enrollment
27
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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