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

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00826176

Purpose

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.

Condition	Intervention	Phase
Anesthesia, General Neuromuscular Relaxation	Drug: Sugammadex	Phase III

Genetics Home Reference related topics: ataxia-telangiectasia

MedlinePlus related topics: Anesthesia

Drug Information available for: Rocuronium Sugammadex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 Blockade of 1-2 PTC Induced by Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia

Further study details as provided by Organon:

Primary Outcome Measures:

Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.9 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.7 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.8 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment:	151
Study Start Date:	September 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sugammadex: Experimental At 1-2 PTC after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex will be administered.	Drug: Sugammadex After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium will be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV can be administered if necessary. At 1-2 PTC after the last administration of rocuronium, an i.v. single bolus dose of 4.0 mg/kg sugammadex will be administered.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects of ASA class 1-3 (extremes included), of age between 18 and 64 years (extremes included), who are scheduled for elective surgery under general anesthesia in the supine position, which requires profound neuromuscular blockade using an NMBA, have given written informed consent. For China only: who are of the Chinese race. For Europe only: who are of the Caucasian race.

Exclusion Criteria:

Subjects known or suspected to have neuromuscular disorders affecting Neuromuscular Blockade (NMB)

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.335, P05775
Study First Received:	January 15, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00826176 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; China: State Food and Drug Administration

Study placed in the following topic categories:

Ataxia-Telangiectasia
Rocuronium
Anesthetics
Ataxia Telangiectasia
Propofol

ClinicalTrials.gov processed this record on May 06, 2009