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Phase Pilot

Sugammadex and Decreased Time to Extubation

  • Study HIC#:2000021124
  • Last Updated:07/15/2021

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) who receive Sugammadex as compared to placebo.

  • Age21 years and older
  • GenderBoth
  • Start Date09/18/2017
  • End Date06/30/2020

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.

Eligibility Criteria

Inclusion Criteria:

  • All elective isolated CABG cases 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<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.

Principal Investigator

Sub-Investigators

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