A multi-center, randomized, parallel-group, active-controlled, safety-assessor blinded trial, comparing the efficacy and safety of 2.0 mg.kg-1 sugammadex with 50 µg.kg-1 neostigmine administered at reappearance of T2 after rocuronium in Chinese and European ASA I-III subjects undergoing elective surgery under propofol anesthesia - Ming Lia

• Conditions: ot applicable

• Registration Number: EUCTR2007-006304-37-BE
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Male or female subjects:
1. of ASA class 1-3 (extremes included)
2. of age between 18 and 64 years (extremes included)
3. who are scheduled for elective surgery under general anesthesia in the supine position, which requires neuromuscular blockade using rocuronium
4. have given written informed consent
5. For China only: who are of the Chinese race, i.e. Chinese descent born in China, never immigrated out of China and have a Chinese home address
6. For Europe only: who are of the Caucasian race, i.e. Caucasian descent born in Europe, never immigrated out of Europe and have a European home address
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

1. Subjects known or expected to have a difficult intubation because of anatomical malformations
2. Subjects known or suspected to have neuromuscular disorders affecting NMB
3. Subjects known or suspected to have a significant renal or hepatic dysfunction
4. Subjects known or suspected to have (family) history of malignant hyperthermia
5. Subjects known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
6. Subjects receiving or for whom it is planned to administer medication expected to interfere with the effect of rocuronium as given in this trial, based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+ (Note, Chinese herbal medicines are allowed)
7. Female subjects who are pregnant (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. Female subjects who are breast-feeding
9. Subjects who have already participated in a previous trial with sugammadex
10. Subjects who participated in another clinical trial not pre-approved by NV Organon, within 30 days of entering into trial 19.4.324

Study & Design

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