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)

This study has been completed.
Information provided by:
Schering-Plough Identifier:
First received: May 15, 2007
Last updated: October 2, 2009
Last verified: October 2009

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Schering-Plough:

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
Experimental: 1
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.
Other Name: Org 25969
Active Comparator: 2
Drug: succinylcholine
Subjects were to receive an intubation dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.


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

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

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough Identifier: NCT00474253     History of Changes
Other Study ID Numbers: 19.4.303
Study First Received: May 15, 2007
Last Updated: October 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Nondepolarizing Agents processed this record on April 17, 2014