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NCT01837498 · ClinicalTrials.gov registry record
Reversal of Neuromuscular Blockade in Thoracic Surgical Patients
A clinical trial, sponsored by Endeavor Health.
- Completed
- Registry status
- 200
- Enrollment target
NCT01837498: Completed study, sponsored by Endeavor Health.
NCT01837498 is a clinical trial that has completed, run by Endeavor Health. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01837498 has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study Summary
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)
Primary Outcome
The incidence of residual neuromuscular block will be calculated on arrival to the PACU
Interventions
- DRUG Sugammadex
- DRUG Neostigmine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-03 |
What the finished NCT01837498 record still lists
NCT01837498 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Sugammadex is the first listed.
NCT01837498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01837498 about?
NCT01837498 is a clinical study titled "Reversal of Neuromuscular Blockade in Thoracic Surgical Patients". 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 effecti...
What is the current status of trial NCT01837498?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2014-02. Estimated completion is 2017-03.
What interventions are being tested in trial NCT01837498?
The interventions under investigation include: Sugammadex (DRUG), Neostigmine (DRUG).
Who is sponsoring clinical trial NCT01837498?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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