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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00675792 |
The primary purpose of this study is to compare the incidence of residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade with 4 mg.kg-1 sugammadex to 50 µg.kg-1 neostigmine. Residual neuromuscular blockade is defined as T4/T1 ratio of < 0.90.
Condition | Intervention | Phase |
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Anesthesia |
Drug: sugammadex Drug: Neostigmine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Parallel Group, Comparative, Active Controlled, Safety-Assessor Blinded, Anesthesiologist-TOF-Watch® SX Blinded Trial Comparing T4/T1 Ratio at Time of Tracheal Extubation Using 4 mg/kg Sugammadex Administered at 1-2 PTCs or Better After the Last Dose of Rocuronium Bromide to 50 µg/kg Neostigmine Administered as Per Standard of Care in Adult Subjects Undergoing Elective Open Abdominal Procedures Requiring Neuromuscular Blockade Reversal |
Enrollment: | 114 |
Study Start Date: | May 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sugammadex: Experimental
4 mg/kg sugammadex
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Drug: sugammadex
This group will receive 4 mg/kg sugammadex at 1-2 PTCs or better after the last dose of rocuronium bromide
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Neostigmine: Active Comparator
50 µg/kg neostigmine
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Drug: Neostigmine
This treatment group will receive 50 µg/kg neostigmine with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care.
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Undetected residual neuromuscular blockade is common in the post-anesthesia care unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle relaxants in operating room have T4/T1 ratios <0.7-0.8 in the PACU. Respiratory and pharyngeal muscle function can be adversely affected during minimal neuromuscular blockade. Studies in awake volunteers and surgical patients have demonstrated that T4/T1 ratios of 0.7 - 0.9 are associated with impaired airway protective reflexes, upper airway obstruction, a decreased hypoxic ventilatory response, and post-operative hypoxemia. The incidence and severity of residual neuromuscular blockade at the time of tracheal extubation will be evaluated and determined how these will influence the length of stay in the operating room and post-anesthesia care unit.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 19.4.334 |
Study First Received: | May 7, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00675792 |
Health Authority: | United States: Food and Drug Administration |
Neostigmine Ataxia-Telangiectasia Bromides |
Rocuronium Glycopyrrolate Ataxia Telangiectasia |
Parasympathomimetics Neuromuscular Nondepolarizing Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors Neuromuscular Blocking Agents |
Neuromuscular Agents Cholinergic Agents Pharmacologic Actions Cholinesterase Inhibitors Autonomic Agents Peripheral Nervous System Agents |