Trial Purpose and Description
To demonstrate faster time to extubation after arrival in the cardiothoracic ICU in patients undergoing isolated CABG who receive study drug (Sugammadex 2mg/kg) as compared to placebo.
Ages: 21 years and younger
- All elective isolated CABG cases in adult patients with preoperative left ventricular ejection fraction (LVEF) ≥45%.
- 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<36.2 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.
Merck Sharp & Dohme
Start Date: 09/18/2017
End Date: 12/31/2017
Last Updated: 02/22/2018
Study HIC#: 2000021124