Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia, General; Neuromuscular Blockade

Treatments: Drug: Sugammadex; Drug: neostigmine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00825812

P05768

19.4.324

Details and patient eligibility

About

The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.

Enrollment: 308 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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308 participants in 4 patient groups

Sugammadex in Caucasian Subjects

Experimental group

Description:

At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.

Treatment:

Drug: Sugammadex

Neostigmine in Caucasian Subjects

Active Comparator group

Description:

At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.

Treatment:

Drug: neostigmine

Sugammadex in Chinese Subjects

Experimental group

Description:

At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.

Treatment:

Drug: Sugammadex

Neostigmine in Chinese Subjects

Active Comparator group

Description:

At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.

Treatment:

Drug: neostigmine