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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00298831
First received: March 1, 2006
Last updated: May 7, 2014
Last verified: May 2014
  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

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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional 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
Study First Received: March 1, 2006
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014