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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298831
First Posted: March 3, 2006
Last Update Posted: August 22, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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 Intervention Phase
Anesthesia, General Drug: sugammadex Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Secondary Outcome Measures:
  • Time from start of administration of Org 25969 to recovery of theT4/T1 ratio to 0.7 and 0.8; [ Time Frame: After surgery ]
  • 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 ]

Enrollment: 224
Actual Study Start Date: October 27, 2005
Study Completion Date: May 22, 2006
Primary Completion Date: May 22, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sugammadex
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
No Contacts or Locations Provided
  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: NCT00298831     History of Changes
Other Study ID Numbers: P05943
19.4.311
First Submitted: March 1, 2006
First Posted: March 3, 2006
Last Update Posted: August 22, 2017
Last Verified: August 2017

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