Residual Neuromuscular Blockade
Conditions
Keywords
Residual neuromuscular blockade, Reversal, Cardiac surgery
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.
Interventions
DRUGneostigmine/glycopyrolate
No additional information
DRUGSugammadex
No additional information
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from arrival in CVICU until extubation | through study completion, an average of 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 28 days following the surgery | — |
| Tidal volumes prior to extubation | Prior to extubation, the tidal volumes the patient is generating will be documented | — |
| Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula | through study completion, an average of 1 year | Assess how many liters of oxygen the patient requires to maintain pulse oximetry \>92% |
| Intensive care unit length of stay | through study completion, an average of 1 year | — |
| Number of participants requiring re-intubation | 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 |
| Bronchoscopy | through study completion, an average of 1 year | Change in baseline oxygen requirements from prior to the surgery |
| Pneumonia | through study completion, an average of 1 year | Change in baseline oxygen requirements from prior to the surgery |
| Lowest documented pulse oximetry | through study completion, an average of 1 year | — |
Countries
United States
Outcome results
None listed