Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)

Condition(s) targeted: Anesthesia, General; Neuromuscular Blockade

Intervention: Sugammadex (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Official title: A Multi-center, Open Label Trial, to Show Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex Administered at a Depth of Neuromuscular Blockade of 1-2 PTC Induced by Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9

Secondary outcome:

Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7

Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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.

Starting date: January 2010
Last updated: October 31, 2014