Comparison Sugammadex Administered at 1-2 PTCs or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adult Subjects Undergoing Elective Open Abdominal Procedure (19.4.334)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00675792

Purpose

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
Anesthesia	Drug: sugammadex Drug: Neostigmine	Phase III

Genetics Home Reference related topics: ataxia-telangiectasia

MedlinePlus related topics: Anesthesia Ataxia Telangiectasia Nausea and Vomiting

Drug Information available for: Neostigmine Neostigmine bromide Neostigmine Methylsulfate Rocuronium ORG 9426 Sugammadex Glycopyrrolate

U.S. FDA Resources

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

Further study details as provided by Organon:

Primary Outcome Measures:

Evidence of residual neuromuscular blockade or evidence of re-occurrence of neuromuscular blockade [ Time Frame: within the first 24 hours after tracheal extubation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evidence of post-operative complications like nausea, vomiting, and post-operative respiratory complications [ Time Frame: within 7 days after surgery ] [ Designated as safety issue: Yes ]
Evidence due to possible interaction of sugammadex with an endogenous or exogenous compound other than rocuronium bromide [ Time Frame: within 7 days after surgery ] [ Designated as safety issue: Yes ]

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
Sugammadex: Experimental 4 mg/kg sugammadex	Drug: sugammadex This group will receive 4 mg/kg sugammadex at 1-2 PTCs or better after the last dose of rocuronium bromide
Neostigmine: Active Comparator 50 µg/kg neostigmine	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects who are >=18 and <=65 years of age;
Subjects of ASA Class 1 or 2 or 3;
Subjects with a Body Mass Index (BMI) of <35 kg/m^2;
Subjects who are scheduled to undergo an elective open abdominal surgical procedure under general anesthesia requiring neuromuscular relaxation using rocuronium bromide (maintenance of neuromuscular blockade if required) for endotracheal intubation and requiring neuromuscular blockade reversal;
Subjects who are scheduled to undergo a surgical procedure in a position that does not interfere with the use of TOF-Watch® SX;
Subjects who are scheduled to undergo an elective open abdominal procedure expected to last <=4 hours (from start of skin incision to end of last stitch of the skin);
Subjects who have given written informed consent.

Exclusion Criteria:

Subjects in whom a difficult intubation is expected because of anatomical malformations;
Subjects known or suspected to have neuromuscular disorders that may impair neuromuscular blockade;
Subjects known or suspected to have significant renal dysfunction (e.g., creatinine clearance < 30 mL/min) ;
Subjects known or suspected to have significant hepatic dysfunction;
Subjects known or suspected to have a (family) history of malignant hyperthermia;
Subjects known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia;
Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
Subjects in whom a pre-established need for postoperative intensive care admission is expected;
Female subjects who are pregnant;
Female subjects who are breast-feeding;
Subjects who have participated in a previous sugammadex clinical trial;

Contacts and Locations

No Contacts or Locations Provided

More Information

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

Study placed in the following topic categories:

Neostigmine
Ataxia-Telangiectasia
Bromides

Rocuronium
Glycopyrrolate
Ataxia Telangiectasia

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009