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

Neuromuscular Blockade Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826176
• Other study ID #: P05775
• Secondary ID: 19.4.335
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2009
• Last updated: October 6, 2015
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anesthesia, General
• Neuromuscular Blockade

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 Anest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No