Comparison of Recovery From Rocuronium 1.2 mg/kg Followed By Org 25969 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00474253

Purpose

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg Zemuron® after reversal at 3 minutes by 16.0 mg/kg of Org 25969 compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

Condition	Intervention	Phase
Anesthesia, General	Drug: Sugammadex Drug: succinylcholine	Phase III

Drug Information available for: Rocuronium ORG 9426 Sugammadex Succinylcholine Succinylcholine chloride Suxamethonium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Parallel Group, Comparative, Active-Controlled, Safety-Assessor Blinded, Phase IIIa, Trial, in Adult Subjects Comparing Recovery From 1.2 mg.kg-1 Rocuronium Followed by 16 mg.kg-1 Org 25969 at 3 Minutes With Recovery From 1.0 mg.kg-1 Succinylcholine

Further study details as provided by Organon:

Primary Outcome Measures:

Recovery of T1 to 10% from start of rocuronium or succinylcholine administration [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Recovery of T1 to 90% from start of rocuronium or succinylcholine administration and clinical signs of recovery (level of consciousness, 5-second head lift, general muscle weakness) [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Enrollment:	115
Study Start Date:	February 2006
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental rocuronium plus Org 25969	Drug: Sugammadex Subjects were to receive an intubating dose of 1.2 mg/kg rocuronium followed by 16.0 mg/kg Org 25969 three minutes after the start of rocuronium administration.
2: Active Comparator succinylcholine	Drug: succinylcholine Subjects were to receive an intubation dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA Class 1 or 2;
18 to 65 years of age (inclusive);
Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
Scheduled for surgery in supine position;
Body mass index (BMI) < 30;
Given written informed consent.

Exclusion Criteria:

Subjects with ischemic heart disease or history of myocardial infarction within the last year;
Subjects in whom a difficult intubation is expected due to anatomical malformations;
Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
Subjects known or suspected to have a (family) history of malignant hyperthermia;
Subjects known or suspected to have an allergy to narcotics, muscle relaxants, midazolam, anesthetics or other medications used during surgery;
Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
Female subjects who are pregnant or breast-feeding;
Females subjects of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence];
Subjects who had already participated in a Org 25969 trial including Protocol 19.4.303;

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.303
Study First Received:	May 15, 2007
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00474253
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Succinylcholine
Rocuronium

Additional relevant MeSH terms:

Neuromuscular Nondepolarizing Agents
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents
Neuromuscular Agents

Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009