Overview
Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)
Status:
Completed
Completed
Trial end date:
2010-08-01
2010-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Merck Sharp & Dohme Corp.Treatments:
Rocuronium
Criteria
Inclusion Criteria:-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are
American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for
elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which
requires neuromuscular blockade using
rocuronium; be compliant with the dose/visit schedules, and use an accepted method of
contraception (if applicable).
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.
Exclusion Criteria:
-Subjects with expected difficult intubation, neuromuscular disorders affecting
neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet,
(family) history of malignant hyperthermia, allergy to general anesthesia medications,
contraindication to study drugs, breast feeding, pregnant, participation in previous or new
trials, a clinically significant condition that may interfere with the trial, or membership
in the
(family of) study/sponsor staff.