None listed
Conditions
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects: • of ASA Class 1 or 2 or 3; • between the ages of 18 to 64 years, inclusive; • scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium; • scheduled for a surgical procedures in supine position; • who have given 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects in whom a difficult intubation because of anatomical malformations is expected; • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic and/or renal dysfunction; • Subjects with a medical or physical condition that is expected to interfere with the proper conduct of simultaneous neuromuscular monitoring on both arms; • Subjects known or suspected to have a (family) history of malignant hyperthermia; • Subjects known or suspected to have arthritis or another disease that will cause the thumb not to move freely; • Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia; • Subjects receiving medication in a dose and/or at a time point known to interfere with NMBAs, such as antibiotics, anticonvulsants and Mg2+; • Subjects who have already participated in a sugammadex trial; • Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.313; • Female subjects who are pregnant*; • Female subjects who are breast-feeding. * In female subjects pregnancy will be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): • Time from start administration of 4.0 mg.kg-1 sugammadex to recovery of the T4/T1 ratio to 0.9 (TOF-Watch® SX); • Time from start administration of 4.0 mg.kg-1 sugammadex to reappearance of T4 (Peripheral Nerve Stimulator). Note: The relation between these two times will be determined within subjects. ;Main Objective: To determine the relation within a subject between the time to manual detection of the reappearance of T4 measured using a peripheral nerve stimulator and the time to recovery of the T4/T1 ratio to 0.9 measured using a TOF-Watch® SX, of 4.0 mg.kg-1 sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg.kg-1 rocuronium or the last maintenance dose of 0.15 mg.kg-1 rocuronium. | — |
Countries
Sweden
Outcome results
None listed