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Clinical Trials/EUCTR2014-004565-24-BE
EUCTR2014-004565-24-BE
Active, not recruiting
Phase 1

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

PAION UK Limited0 sites530 target enrollmentJune 2, 2015
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ConditionsAnesthesia in adult patients undergoing cardiac surgery.MedDRA version: 18.0Level: LLTClassification code 10021722Term: Induction and maintenance anaesthesiaSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsPropofol 1% MCT Fresenius

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Anesthesia in adult patients undergoing cardiac surgery.
Sponsor
PAION UK Limited
Enrollment
530
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 2, 2015
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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
  • •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

Outcomes

Primary Outcomes

Not specified

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