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Reversal of Neuromuscular Blockade in Thoracic Surgical Patients

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ClinicalTrials.gov Identifier: NCT01837498
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Glenn Murphy, NorthShore University HealthSystem

Brief 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)

Condition or disease Intervention/treatment
Residual Neuromuscular Blockade Drug: Neostigmine Drug: Sugammadex

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reversal of Neuromuscular Blockade in Thoracic Surgical Patients
Actual Study Start Date : February 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

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Group/Cohort Intervention/treatment
Neostigmine group
At the conclusion of the surgical procedure, neuromuscular block will be reversed with neostigmine
Drug: Neostigmine
At the conclusion of the surgical procedure, neuromuscular block will be reversed with neostigmine

Sugammadex group
At the conclusion of the surgical procedure, neuromuscular block will be reversed with sugammadex
Drug: Sugammadex
At the conclusion of the surgical procedure, neuromuscular block will be reversed with sugammadex




Primary Outcome Measures :
  1. Residual neuromuscular block (train-of-four ratio (TOF) < 0.9) [ Time Frame: On admission to the postanesthesia care unit (PACU), up to 7 days ]
    The incidence of residual neuromuscular block will be calculated on arrival to the PACU


Secondary Outcome Measures :
  1. Time in operating room [ Time Frame: participants will be followed for the duration of the operating room stay, an expected average of 2 hours, up to 7 days ]
  2. Hypoxemic events [ Time Frame: participants will be followed for the duration of the PACU stay, an expected average of 2 hours, up to 7 days ]
    Blood oxygenation values will be measured using pulse oximetry from the time of PACU admission until discharge from the PACU

  3. Tests of muscle weakness [ Time Frame: 15 and 30 minutes after admission to the PACU, up to 7 days ]
    A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups

  4. Length of stay in the PACU [ Time Frame: participants will be followed for the duration of the PACU stay, an expected average of 2 hours, up to 7 days ]
    The time required to meet discharge criteria and achieve actual discharge will be noted.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
200 patients presenting for elective thoracic surgical procedures with an expected duration greater than 45 minutes will be enrolled in this study. The study is designed as a "before and after" investigation of sugammadex (data will be collected on 100 consecutive patients before sugammadex is approved by the FDA for clinical care in the United States (neostigmine used), and on 100 consecutive patients after sugammadex is approved). 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)
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837498


Locations
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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Glenn S Murphy, MD NorthShore University HealthSystem

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Responsible Party: Glenn Murphy, Director, Clinical Research, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01837498    
Other Study ID Numbers: EH13-031
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Keywords provided by Glenn Murphy, NorthShore University HealthSystem:
residual neuromuscular blockade, sugammadex, neostigmine, thoracic surgery
Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents