None listed
Conditions
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cardiac patients (i.e. patients with ischemic heart disease, chronic heart failure or arrhythmia), of NYHA Class II to III 2. ASA class maximally 4 (class 4 only because of NYHA class III) 3. Age at least 18 years 4. Scheduled for elective, non-cardiac surgery under general anesthesia with propofol in the supine position, with planned muscle relaxation using rocuronium and allowing for 12-lead ECG assessment during surgery 5. Written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Disorders interfering with the reliability of the assessments (e.g. ECG measurements), such as paroxysmal atrial fibrillation or the presence of a pacemaker 2. Known or suspected neuromuscular disorders impairing NMB 3. Known or suspected significant renal dysfunction 4. Known or suspected (family) history of malignant hyperthermia 5. Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia 6. (Intended) use of medication expected to interfere with the effect of rocuronium as given in this trial, based on the dose and/or the time of administration (such as antibiotics, anticonvulsants and Mg2+) 7. Pregnancy (pregnancy will be excluded for women both from medical history and by an hCG test within 24 h before surgery, except for women who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy) 8. Childbearing potential without using any method of birth control or using only hormonal contraception as birth control (patients are allowed to participate if they are willing to use a condom, or a diaphragm with spermicide, or IUD, or have a vasectomized partner (>6 months) or abstinence, for one month after participation in the trial) 9. Breast-feeding 10. Prior participation in any trial with Org 25969 11. Participation in another clinical trial not pre-approved by Organon, within 30 days of entering into trial 19.4.309
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of 2.0 and 4.0 mg.kg-1 Org 25969 in cardiac patients compared to placebo.;Secondary Objective: To evaluate the time to recovery from a neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 and 4.0 mg.kg-1 Org 25969 in cardiac patients.;Primary end point(s): Change from baseline using a one-way ANOVA (with factor treatment) and analyzing pairwise contrasts: heart rate, systolic and diastolic blood pressure and ECG intervals (including QTc interval) at 2, 5, 10 and 30 minutes after IP (baseline= pre-IP). | — |
Countries
Germany
Outcome results
None listed