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-DK
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Each subject must be willing and able to provide written informed consent for the trial.
2. Each subject must be = 18 to = 64 years of age. A subject may be of either sex.
3. For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.
4. Each subject must be scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium.
5. Each subject must be ASA class = 1 to = 3.
6. Each subject must be able to adhere to dose and visit schedules.
7. Each female subject (and male subject whose female partner also provides written informed consent to provide information regarding pregnancy) of childbearing potential must agree to use an accepted method of contraception while receiving protocol-specified medication and for seven days after stopping the medication.

Accepted methods of contraception include contraceptive pills, intrauterine devices, contraceptive injections, subdermal implantation, vaginal ring, and transdermal patches and surgical sterilization (eg, hysterectomy or tubal ligation).

Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period.
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. A subject must not have anatomical malformations leading to an expected difficult intubation.
2. A subject must not have or is not suspected to have neuromuscular disorders affecting NMB.
3. A subject must not have or is not suspected to have a significant renal dysfunction that would prevent participation in this trial as determined by the investigator.
4. A subject must not have or is not suspected to have a significant hepatic dysfunction that would prevent participation in this trial as determined by the investigator.
5. A subject must not be scheduled for a surgery requiring the use of pneumatic tourniquet.
6. A subject must not have or is not suspected to have a (family) history of malignant hyperthermia.
7. A subject must not have or is not suspected to have an allergy to opioids, cyclodextrins (including sugammadex), muscle relaxants or their excipients or other medication used during general anesthesia.
8. A subject must not have a contraindication for use of neostigmine and/or atropine, such as a predisposition to narrow anterior chamber angel glaucoma and untreated glaucoma.
9. A subject must not continue to receive any treatment listed in Table 1 (see protocol) during the current trial.
10. A female subject must not be breast-feeding.
11. A female subject must not be pregnant (pregnancy will be excluded for women both from medical history and by an hCG test (random urine or serum) within 24 hours before surgery, except for women who are not of childbearing potential, ie, at least one year menopausal (at least 12 consecutive months without a spontaneous menstrual period) or have undergone bilateral tubal ligation or bilateral oophorectomy or hysterectomy); or intending to become pregnant.
12. A subject must not have participated in this or a previous sugammadex trial.
13. A subject must not have participated in another investigational drug clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial.
14. A subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
15. A subject must not be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: - to show the time to recovery from a neuromuscular blockade induced by rocuronium after reversal at reappearance of T2 by 2.0 mg.kg-1 sugammadex is faster than by 50 µg.kg-1 neostigmine in Chinese subjects undergoing elective surgery under propofol.;Primary end point(s): The time from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.;Secondary Objective: - to show the time to recovery from a neuromuscular blockade induced by rocuronium after reversal at reappearance of T2 by 2.0 mg.kg-1 sugammadex is faster than by 50 µg.kg-1 neostigmine in Caucasians undergoing elective surgery under propofol;<br>- to show the equivalence in time to recovery from rocuronium induced NMB after reversal at reappearance of T2 by 2.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects;<br>- to evaluate the safety of 2.0 mg.kg-1 sugammadex in subjects undergoing elective surgery compared to 50 µg.kg-1 neostigmine;