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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00298831
First received: March 1, 2006
Last updated: October 2, 2009
Last verified: October 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Time from start of administration of Org 25969 to recovery of theT4/T1 ratio to 0.9. [ Time Frame: After surgery ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 224
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00298831     History of Changes
Other Study ID Numbers: 19.4.311
Study First Received: March 1, 2006
Last Updated: October 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anesthetics
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013