None listed
Conditions
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects of ASA class 1 to 4, above or equal to the age of 18 years; • Subjects scheduled for surgical procedure with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block; • Subjects scheduled for surgical procedures in supine position; • Subjects 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) yes 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 NMB and/or significant renal dysfunction; • Subjects known or suspected to have a (family) history of malignant hyperthermia; • 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 NMBA, such as antibiotics, anticonvulsants and Mg2+; • Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated; • Subjects who have already participated in an Org 25969 trial; • Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.301; • Female subjects who are pregnant; • Female subjects of childbearing potential not using any method of birth control or using only hormonal contraception as birth control; • Female subjects who are breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate faster recovery from a neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 mg.kg-1 Org 25969 compared to 50 µg.kg-1 neostigmine. • To demonstrate faster recovery from a neuromuscular block induced by vecuronium after reversal at reappearance of T2 by 2.0 mg.kg-1 Org 25969 compared to 50 µg.kg-1 neostigmine. ; Secondary Objective: To evaluate the safety of a single dose of 2.0 mg.kg-1 Org 25969 and 50 µg.kg-1 neostigmine administered in adult subjects. ; Primary end point(s): Time from start of administration of Org 25969/neostigmine to recovery of the T4/T1 ratio to 0.9. Note: The recovery from NMB at reappearance of T2 between Org 25969 and neostigmine will be compared. | — |
Countries
Austria, Belgium, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed