The purpose of this study is to examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting patients. This study is a prospective, clinical interventional, randomized single blinded single-center design. The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
Enhanced recovery pathways and early extubation of subjects undergoing cardiac procedures has now become mainstay, especially with the advent of minimally invasive procedures . To facilitate optimal recovery after extubation; muscle strength is vital to prevent reintubation, improved deglutition and quicker transition to lower oxygen requirements, and better respiratory and cardiac hemodynamics. It also expedites de-escalation of acuity of care. Several studies have shown residual muscle weakness after full reversal with neostigmine and glycopyrrolate. Sugammadex is a direct reversal agent and can provide superior muscle strength, which optimizes respiratory function thereby preventing atelectasis, hypoxia and potentially avoiding reintubation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure.
Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage)
Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage)
WVU Medicine
Morgantown, West Virginia, United States
Time to Extubation
Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart "procedure stop." The definition for "time to extubation" is from the time the investigators chart "procedure stop" to the time of "extubation".
Time frame: 0 minutes of study drug to 3 days after study drug administration
Heart Rate
Heart rate post-reversal prior to extubation
Time frame: 0 minutes to 2 hours after study drug administration
Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)
Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea
Time frame: 0 minutes to 2 hours after study drug administration
Tidal Volume
Tidal volume post-reversal prior to extubation
Time frame: between 30 minutes to 1 hour after extubation
Peak Flow Rate
Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins
Time frame: 30-60 minutes post-extubation
Swallowing Capacity
In the intensive care unit: If the patient awake and alert, is able to be positioned, can cough when asked, able to follow command to lick top and bottom lip, and is able to breathe freely then a registered nurse bedside swallowing/dysphagia screen is performed at a time point somewhere between 30 and 60 minutes following the operating room extubation. To perform the screen, a teaspoon is used to place distilled water on each subject's tongue, 3 mL each time 2 consecutive times. Then 3 ounces of water intake. The patient is asked to swallow the water to evaluate the swallowing ability. Aspiration of fluid (choking) subjectively divided into 4 categories: normal, no choking or hoarse voice after swallowing; mild, no choking but slight hoarseness of voice; moderate, no choking but a clearly identifiable hoarseness of voice; severe, choking.
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Reversal with Sugammadex (2mg/kg)
Time frame: Between 30 and 60 minutes post-extubation