Reversal of Neuromuscular Blockade in Thoracic Surgical Patients
Completed
Conditions studied: Residual Neuromuscular Blockade
In brief
The majority of patients undergoing surgery receive neuromuscular blocking agents (NMBAs) in the operating room. Reversal of neuromuscular blockade at the conclusion of a general anesthetic is accomplished with cholinesterase inhibitors (primarily neostigmine). Although these drugs are often effective in enhancing recovery of muscle strength, the onset of effect is often slow (usually 15-30 minutes). More effective neuromuscular reversal agents are needed in clinical practice to enhance surgical and anesthetic management of perioperative patients. A new reversal agent (sugammadex) will likely be approved for clinical use in the United States next year. Unlike neostigmine, sugammadex is effective in providing rapid antagonism of all levels of neuromuscular blockade (typically within 2-4 minutes). The aim of this prospective observational study is to study neuromuscular and clinical recovery in 100 consecutive thoracic surgical patients receiving neostigmine, followed by a 100 consecutive thoracic surgical patients administered sugammadex (after the drug is approved by the FDA). In addition, after data on 100 patients reversed with neostigmine is collected, the data will be analyzed to compare patients with residual block (train-of four \< 0.9) and without residual block (TOF \</= 0.9)
Key facts
- Study ID
- NCT01837498
- Run by
- Endeavor Health
- People needed
- 200
- Starts
- 2014-02-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2020-02-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ASA I to III patients 18-80 years of age, presenting for surgery requiring maintenance of neuromuscular blockade in the operating room, will be eligible for enrollment.
You may not qualify if…
- Exclusion criteria include: 1) presence of an underlying neuromuscular disease 2) use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate) or 3) renal insufficiency (serum creatinine > 1.8 mg/dL) or renal failure.
Where it is running
- NorthShore University HealthSystem — Evanston, Illinois, United States
Full record on ClinicalTrials.gov
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