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Comparison of Org 25969 With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (19.4.301)(P05960)

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ClinicalTrials.gov Identifier: NCT00451217
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : June 16, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study was to demonstrate in adult patients faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 by 2.0 mg/kg Org 25969 (sugammadex) compared to 50 ug/kg neostigmine.

Condition or disease Intervention/treatment Phase
Anesthesia, General Drug: Sugammadex Drug: neostigmine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium at Reappearance of T2
Actual Study Start Date : November 17, 2005
Primary Completion Date : March 6, 2006
Study Completion Date : March 6, 2006

Arms and Interventions

Arm Intervention/treatment
Experimental: Sugammadex Drug: Sugammadex
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg Org25969 was to be administered
Other Name: Org 25969
Active Comparator: neostigmine Drug: neostigmine
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Other Name: premix neostigmine/glycopyrrolate

Outcome Measures

Primary Outcome Measures :
  1. Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9. [ Time Frame: After surgery ]

Secondary Outcome Measures :
  1. Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8; assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, general muscle weakness) [ Time Frame: After surgery ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects of ASA 1 - 4;
  • Subjects above or equal to the age of 18;
  • Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
  • Scheduled for surgical procedure in supine position;
  • Given written informed consent.

Exclusion Criteria:

  • Subjects in whom a difficult intubation because of anatomical malformations was expected;
  • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) 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 or other medication used during general anesthesia;
  • Subjects receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
  • Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
  • Subjects who had already participated in an Org 25969 trial;
  • Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.301.
  • Female subjects who are pregnant:
  • Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
  • Female subjects who were breast-feeding.
More Information

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00451217     History of Changes
Other Study ID Numbers: P05960
Aurora Trial
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Vecuronium Bromide
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Autonomic Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Nicotinic Antagonists