Comparison of the T4/T1 ratio measured by means of the TOF-Watch® SX with the reappearance of T4 measured by means of a peripheral nerve stimulator in adult subjects receiving 4.0 mg.kg-1 sugammadex at 15 minutes after rocuronium

• Conditions: ot applicable

• Registration Number: EUCTR2007-002911-18-AT
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-11
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified