A multi-center, randomized, parallel-group, comparative, active-controlled, safety-assessor blinded trial in adult subjects comparing the efficacy and safety of sugammadex administered at 1-2 PTC with neostigmine administered at reappearance of T2 in subjects undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia - Moonlight
- Conditions
- ot applicable
- Registration Number
- EUCTR2007-007951-14-DE
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
Male or female subjects:
• Subjects of ASA class 1-3
• Subjects of age above or equal to the age of 18 years
• Subjects who are scheduled to undergo a laparoscopic cholecystectomy or appendectomy under general anesthesia requiring neuromuscular relaxation with rocuronium, and if applicable, maintenance of neuromuscular blockade
• 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
• Subjects in whom a difficult intubation because of anatomical malformations is expected
• Subjects known or suspected to have neuromuscular disorders affecting NMB
• Subjects known or suspected to have a significant renal dysfunction
• Subjects known or suspected to have a severe hepatic dysfunction
• Subjects known or suspected to have (family) history of malignant hyperthermia
• Subjects known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
• Subjects in whom the use of neostigmine and/or atropine is contraindicated
• Female subjects who are pregnant (pregnancy will be excluded for women both from medical history and by an hCG test within 24h before surgery, except for women who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy)
• Female subjects who are breast-feeding
• Subjects who participated in another clinical trial not pre-approved by the sponsor, within 30 days of entering into trial 19.4.318
• Subjects who have already participated in a sugammadex trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • to demonstrate faster recovery to a T4/T1 ratio of 0.9 measured with a TOFWatch® SX from a neuromuscular blockade induced by rocuronium after reversal at 1-2 PTC by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of T2 in subjects undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia.;Secondary Objective: • to compare the safety of a single dose of 4.0 mg.kg-1 sugammadex in subjects undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia with 50 µg.kg-1 neostigmine;Primary end point(s): The time from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.
- Secondary Outcome Measures
Name Time Method