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Clinical Trials/EUCTR2013-001113-32-DE
EUCTR2013-001113-32-DEActive, not recruitingNot Applicable

A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics 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 sitesStarted: April 26, 2013Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Patients scheduled for major elective cardiac surgery, i.e. 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 and surgery of the aortic arch
  • •Scheduled to receive mechanical ventilation via tracheal intubation (oropharyngeal or nasotracheal)
  • •Age at least 18 years
  • •Weight between 55 and 150 kg inclusive
  • •Body Mass Index (BMI) 18 to = 35 kg/m2
  • •Willingness and ability to give informed consent, to understand, participate and comply with all study requirements
  • •For women with childbearing potential: negative pregnancy test
  • •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 36
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

  • •Thoraco-abdominal replacement of the aorta or other procedure expected to be accompanied by a massive hemorrhage (at least 15% of the circulating blood volume)
  • •History of or planned cooling below 34ºC
  • •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)
  • •Severe renal insufficiency or end-stage renal disease (estimated glomerular filtration rate below 30 mL/min/1.73 m2)
  • •Clinically uncontrolled coagulation abnormalities, or coagulation abnormalities not under adequate treatment
  • •Total bilirubine =3.0 mg/dL or AST and/or ALT =2.5 x ULN during 7 days prior to starting administration of the investigational product
  • •Scheduled for heart or lung transplantation
  • •Infectious cardiac disorders (e.g. endocarditis, myocarditis)
  • •Emergency surgery, status of shock or coma
  • •Ejection fraction of less than 20%
  • •Acute right heart failure
  • •Pre-operative use of phosphodiesterase 3 inhibitors
  • •History of resuscitation
  • •Known resistance to benzodiazepines or history of paradoxical effects after administration of benzodiazepines
  • •History of hypersensitivity to benzodiazepines, propofol, remifentanil hydrochloride, rocuronium bromide, flumazenil or other anesthetic agents
  • •Use of benzodiazepines within 5 times their half-life or 5 times the half-life of their active metabolites. Exception: Single dose pre-medication before the surgery according to local standards is allowed.
  • •Myasthenia gravis or myasthenic syndrome
  • •History of any severe allergy
  • •Dependence from alcohol or drugs or history of alcohol or drug abuse
  • •Acute alcoholic intoxication or ethanol intake within 48 hours prior to surgery
  • •Acute narrow-angle glaucoma
  • •Female patients of childbearing potential without acceptable method of birth control or not surgically sterile
  • •Pregnant or breast feeding female patients
  • •Patients in receipt of any investigational drug within 30 days or less than 7 half-lives (whichever was longer) before the start of the study , or scheduled to receive one during the study period
  • •Administration of remimazolam in the past
  • •Unable to communicate well with the investigator
  • •Other reasons that, according to the investigator, exclude the patient from the trial

Investigators

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