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Use of Sugammadex at the End of Case in Routine Anesthesia (19.4.311)(P05943)

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: NCT00298831
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 after a dose of sugammadex when administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Phase IIIa Trial to Evaluate the Efficacy and Safety of Org 25969 When Used at the End of Surgical Procedure to Reverse the Neuromuscular Block Induced by Rocuronium Following Routine Anesthesia
Actual Study Start Date : October 27, 2005
Primary Completion Date : May 22, 2006
Study Completion Date : May 22, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: sugammadex

Each subject will receive an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block is required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium may be administered.

At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 will be administered.

Other Name: Org 25969

Primary Outcome Measures :
  1. Time from start of administration of Org 25969 to recovery of theT4/T1 ratio to 0.9. [ Time Frame: After surgery ]

Secondary Outcome Measures :
  1. Time from start of administration of Org 25969 to recovery of theT4/T1 ratio to 0.7 and 0.8; [ Time Frame: After surgery ]
  2. Clinical assessments of recovery, i.e., level of consciousness, 5-second head lift, and check for general muscle weakness, prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. [ Time Frame: After surgery ]

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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:

  • ASA Class 1-3 subjects who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.

Exclusion criteria:

  • Subjects with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
  • Subjects taking medications known to interfere with neuromuscular blocking agents.
  • Subject who are of child-bearing potential, pregnant, and breast feeding

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00298831     History of Changes
Other Study ID Numbers: P05943
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs