Comparison of rocuronium and Org 25969 with cis-atracurium and neostigmine when neuromuscular block is reversed at reappearance of T2

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

• Subjects of ASA class 1 to 4, above or equal to the age of 18 years;
• Subjects scheduled for surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cis-atracurium;
• 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

• 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 known to interfere with NMBA, such as anticonvulsants and Mg2+;
• Subjects contra-indicated for the use of neostigmine and/or glycopyrrolate;
• 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 19.4.310;
• 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show a faster recovery of neuromuscular block with Org 25969 after rocuronium as compared to neostigmine after cis-atracurium when administered at reappearance of T2.;<br> 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.<br> • To show a faster onset of neuromuscular block after 0.6 mg.kg-1 rocuronium as compared to 0.15 mg.kg-1 cis-atracurium.<br> ;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).

Secondary Outcome Measures

Name	Time	Method

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