Sugammadex and Decreased Time to Extubation

• Status: Completed
• Trial end date: 2020-10-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Merck Sharp & Dohme Corp.

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.