Use of Sugammadex at the End of Case in Routine Anesthesia (19.4.311)(P05943)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: March 1, 2006
Last updated: May 13, 2016
Last verified: May 2016
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2006 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov processed this record on May 25, 2016
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 1, 2006
||May 13, 2016
||United States: Food and Drug Administration