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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General; Neuromuscular Blockade
• Intervention / Treatment: Drug: Sugammadex

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugammadex in Caucasian Subjects; At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.	Drug: Sugammadex; After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.; Other Names: Org 25969, Bridion®
Experimental: Sugammadex in Chinese Subjects; At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.	Drug: Sugammadex; After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.; Other Names: Org 25969, Bridion®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9	Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary.	Start of administration of sugammadex to recovery from neuromuscular blockade

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7	Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.	Start of administration of sugammadex to recovery from neuromuscular blockade
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8	Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.	Start of administration of sugammadex to recovery from neuromuscular blockade

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Yu B, Wang X, Helbo Hansen HS, Huang W-Q, Askeland B, Li S, Ding Z, Abels E, Rietbergen H, Woo T, Pendeville P. Sugammadex 4.0 mg/kg reversal of deep rocuronium-induced neuromuscular blockade: a multicenter study in Chinese and Caucasian patients. J Anesthe Clin Res. 2014;5:408. doi: 10.4172/2155-6148.1000408

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: January 15, 2009
• First Submitted That Met QC Criteria: January 16, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: P05775; 19.4.335