Clinical trial NCT03574337: Residual Neuromuscular Blockade in Cardiac Surgery Patients
Official title: Residual Neuromuscular Blockade in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Residual Neuromuscular Blockade
Keywords: Residual neuromuscular blockade
Reversal
Cardiac surgery
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Time from arrival in CVICU until extubation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Tidal volumes prior to extubation
timeFrame: Prior to extubation, the tidal volumes the patient is generating will be documented
measure: Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula
timeFrame: through study completion, an average of 1 year
measure: Lowest documented pulse oximetry
timeFrame: through study completion, an average of 1 year
measure: Number of participants requiring re-intubation
timeFrame: through study completion, an average of 1 year
measure: Bronchoscopy
timeFrame: through study completion, an average of 1 year
measure: Pneumonia
timeFrame: through study completion, an average of 1 year
measure: Intensive care unit length of stay
timeFrame: through study completion, an average of 1 year
measure: Mortality
timeFrame: 28 days following the surgery
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
Study officials:
affiliation: Henry Ford Health Systems
name: Mary Jarzebowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2.
citation: Richey M, Mann A, He J, Daon E, Wirtz K, Dalton A, Flynn BC. Implementation of an Early Extubation Protocol in Cardiac Surgical Patients Decreased Ventilator Time But Not Intensive Care Unit or Hospital Length of Stay. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):739-744. doi: 10.1053/j.jvca.2017.11.007. Epub 2017 Nov 8.