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

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

ChemIDplus related topics:

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
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 October 10, 2008

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