Status:
COMPLETED
Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia, General
Neuromuscular Blockade
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00826176
Start Date
January 1 2010
End Date
August 1 2010
Last Update
October 7 2015
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