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Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451100
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : November 15, 2019
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed at Reappearance of T2
Actual Study Start Date : November 10, 2005
Actual Primary Completion Date : May 22, 2006
Actual Study Completion Date : August 29, 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sugammadex
2.0 mg/kg Org 25969 (sugammadex)
Drug: Sugammadex
Subjects received a bolus dose of 0.6 mg/kg rocuronium. After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg Org 25969 was to be administered
Other Name: Org 25969

Active Comparator: Neostigmine
50 ug/kg neostigmine
Drug: neostigmine
Subjects received a bolus dose of 0.15 mg/kg cisatracurium. After the last dose of cisatracurium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered. In accordance to the labeling of neostigmine, a maximum of 5 mg neostigmine was to be administered
Other Name: premix neostigmine/glycopyrrolate

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 [ Time Frame: After surgery ]
  2. Assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, and general muscle weakness) [ Time Frame: after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 requiring neuromuscular relaxation with the use of rocuronium or cisatracurium;
  • Scheduled for surgical procedures 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 Org25969 trial;
  • Subjects who had participated in another clinical trial (not pre-approved by NV Organon) within 30 days of entering into CT 19.4.310.
  • 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.
Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00451100    
Other Study ID Numbers: P05931
Crystal Trial
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists