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Residual Neuromuscular Blockade in Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT03574337
Recruitment Status : Not yet recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Prabhdeep Hehar, Henry Ford Health System

Brief Summary:
The purpose of this project is to determine if reversal of neuromuscular blockade in cardiac surgery patients expedites time to extubation in fast track patients.

Condition or disease Intervention/treatment Phase
Residual Neuromuscular Blockade Drug: Sugammadex Drug: neostigmine/glycopyrolate Phase 4

Detailed Description:
Neuromuscular blocking agents are used as part of most general anesthetics to help facilitate tracheal intubation and optimal surgical conditions (Barish et al). These medications cause universal paralysis of patients while unconscious. After most surgeries where extubation is planned, the standard of care is to "reverse" any residual neuromuscular blockade with either anticholinesterase treatment (specifically neostigmine) or sugammadex. Despite adequate reversal, residual neuromuscular blockade is a common problem seen in the post-anesthetic care unit (PACU). It leads to issues of airway obstruction, hypoxemia, respiratory complications including atelectasis and pneumonia and muscle weakness (Brull et al). The investigators posit that these complications are likely amplified in patients who require post-operative intensive care unit admission. In particular, the investigators hypothesize that cardiac surgery patients are at risk. Elective cardiac surgery patients are routinely admitted to the CVICU still intubated and ventilator-dependent immediately following surgery. The goal of uncomplicated cardiac surgery patients (fast track cardiac surgery patients) is to extubate them within 6 hours of ICU arrival. However, standard of care throughout the US does not include reversal of their neuromuscular blockade. By the time these patients meet extubation criteria, most providers believe that the neuromuscular blockade should have worn off and therefore do not administer reversal (Murphy et al). The investigators hypothesize that residual neuromuscular blockade delays time to extubation and increases respiratory complications in fast track cardiac surgery patients. By administering reversal of neuromuscular blockade in patients with a Train Of Four ratio of <0.9 we anticipate that there will be an increase from 60 to 85% of patients being successfully extubated within 6 hours of arrival to the ICU and a decrease in composite respiratory complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Residual Neuromuscular Blockade in Cardiac Surgery Patients
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: Sugammadex
Patient's will receive sugammadex at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight and TOF ratio by the pharmacy. It will be a one time dose at the end of the case
Drug: Sugammadex
No additional information

Active Comparator: Neostigmine/glycopyrrolate
Patient's will receive neostigmine/glycopyrrolate at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight (50mcg/kg of neostigmine with an equivalent volume to volume ratio of glycopyrrolate). It will be a one time dose at the end of the case
Drug: neostigmine/glycopyrolate
No additional information

No Intervention: No reversal administered
No reversal administered at the end of the case



Primary Outcome Measures :
  1. Time from arrival in CVICU until extubation [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Tidal volumes prior to extubation [ Time Frame: Prior to extubation, the tidal volumes the patient is generating will be documented ]
  2. Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula [ Time Frame: through study completion, an average of 1 year ]
    Assess how many liters of oxygen the patient requires to maintain pulse oximetry >92%

  3. Lowest documented pulse oximetry [ Time Frame: through study completion, an average of 1 year ]
  4. Number of participants requiring re-intubation [ Time Frame: through study completion, an average of 1 year ]
    If the patient is extubated in the intensive care unit but then develops respiratory failure and requires mechanical ventilation again

  5. Bronchoscopy [ Time Frame: through study completion, an average of 1 year ]
    Change in baseline oxygen requirements from prior to the surgery

  6. Pneumonia [ Time Frame: through study completion, an average of 1 year ]
    Change in baseline oxygen requirements from prior to the surgery

  7. Intensive care unit length of stay [ Time Frame: through study completion, an average of 1 year ]
  8. Mortality [ Time Frame: 28 days following the surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All outpatients >18 years of age scheduled for elective coronary artery bypass graft surgery (CABG), aortic valve replacement (AVR), or combination CABG/AVR

Exclusion Criteria:

  • Chronic kidney disease stage IV or V
  • Liver disease, defined as AST, ALT or ALP > 1.5x upper limit of normal Inpatient status
  • Allergy to rocuronium

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): NCT03574337


Contacts
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Contact: Prabhdeep Hehar, DO 313-623-9061 phehar1@hfhs.org
Contact: Mary Jarzebowski, MD 313-282-5673 MJarzeb1@hfhs.org

Locations
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United States, Michigan
Henry Ford Health Systems Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Mary Jarzebowski, MD    313-282-5673    mjarzeb1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Mary Jarzebowski, MD Henry Ford Health Systems

Publications of Results:
Other Publications:
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Responsible Party: Prabhdeep Hehar, Anesthesia Resident, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03574337     History of Changes
Other Study ID Numbers: Henryford
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Prabhdeep Hehar, Henry Ford Health System:
Residual neuromuscular blockade
Reversal
Cardiac surgery
Additional relevant MeSH terms:
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Glycopyrrolate
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
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists