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.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00474253
First received: May 15, 2007
Last updated: October 2, 2009
Last verified: October 2009

May 15, 2007
October 2, 2009
February 2006
August 2006   (final data collection date for primary outcome measure)
Recovery of T1 to 10% from start of rocuronium or succinylcholine administration [ Time Frame: After surgery ] [ Designated as safety issue: No ]
Recovery of T1 to 10% from start of rocuronium or succinylcholine administration [ Time Frame: after surgery ]
Complete list of historical versions of study NCT00474253 on ClinicalTrials.gov Archive Site
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 ]
Recovery of T1 to 90% from start of rocuronium or succinylcholine administration and clinical signs of recovery [ Time Frame: after surgery ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia, General
  • 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
  • Drug: succinylcholine
    Subjects were to receive an intubation dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.
  • Experimental: 1
    rocuronium plus Org 25969
    Intervention: Drug: Sugammadex
  • Active Comparator: 2
    succinylcholine
    Intervention: Drug: succinylcholine
Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
August 2006
August 2006   (final data collection date for primary outcome measure)

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;
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00474253
19.4.303
No
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Schering-Plough
Not Provided
Not Provided
Schering-Plough
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP