Sugammadex and Decreased Time to Extubation
Condition: Coronary Artery Bypass Graft and/or Aortic Valve Replacement Surgery
Intervention: Sugammadex; Placebo
Intervention description: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.; The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be enrolled using 1:1 randomization between active ingredient (intervention) and control arms, to be assigned randomly using a computer generated algorithm.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
Enrollment: 90.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: sugammadex; extubation; CABG, AVR, CABG/AVR combination

Summary:

      The purpose of this study is to demonstrate faster time to extubation after arrival in the
      cardiothoracic intensive care unit (ICU) in patients undergoing isolated coronary artery
      bypass grafting (CABG), AVR and AVR/CABG combination who receive Sugammadex as compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All elective ARV, CABG cases, on-pump or off-pump, and CABG/AVR in adult patients with
             preoperative left ventricular ejection fraction (LVEF) ≥45%.

        Exclusion Criteria:

          -  Emergency/unplanned cases.

          -  EF<45% or moderate /severe RV dysfunction.

          -  Estimated GFR < 30 mL/min.

          -  Patients on supplemental oxygen at baseline (home oxygen).

          -  BMI>40 (calculated as the patient's weight in kilograms divided by the square of the
             patient's height in meters).

          -  Patients with chronic opioid use preoperatively.

          -  Patients with known neuromuscular disorders preoperatively.

          -  Patients with a known sensitivity to Rocuronium or to Sugammadex.

          -  Patients with known cognitive deficits preoperatively.

        Exclusions after recruitment but prior to randomization:

          -  Postoperative Bleeding (chest tube output >100cc/hr ).

          -  Treatment of anaphylactoid reaction intraoperatively.

          -  Patient's temperature<35.5 or >38.3 degree Celsius at the time of ICU arrival.

          -  Determination that the patient will require prolonged mechanical ventilation possibly
             requiring muscle relaxation based on the intraoperative course and clinical judgment
             of the study PI or collaborating intensivists.

          -  Intraoperative hypoxia or on arrival to the ICU. (Please see Study Flowchart).

          -  Cardiac arrest.

          -  Sudden arrhythmia (Ventricular tachycardia runs/sudden bradycardia with improper
             pacemaker detection/function) precluding fast-track extubation protocol.

          -  Need for inotrope initiation precluding fast-track protocol.

          -  Postoperative ST changes.