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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007951-14-FI

Enrollment

140

Registered

2008-03-31

Start date

2008-05-05

Completion date

Unknown

Last updated

2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Bridion Product Name: sugammadex Product Code: Org 25969 Pharmaceutical Form: Solution for injection INN or Proposed INN: sugammadex CAS Number: 343306-79-6 Current Sponsor code: Org 25969

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Finland, Germany, United Kingdom

Outcome results