Phase 4
N=90
Sugammadex and Decreased Time to Extubation
Coronary Artery Bypass Graft and/or Aortic Valve Replacement Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03196167 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Time to Extubation — 126.0; 219.0 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Extubation |
126.0; 219.0 | — |
| SECONDARY Negative Inspiratory Force |
-33.0; -31.0 | — |
| SECONDARY RSBI |
40.0; 32.7 | — |
| SECONDARY Length of ICU Stay |
2; 2 | — |
| SECONDARY Length of Hospital Stay |
5; 5 | — |
| SECONDARY New Dysrhythmia |
3; 6 | — |
| SECONDARY Change in Renal Function |
5; 3 | — |
| SECONDARY Postoperative CHF |
0; 1 | — |
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 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 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.
Data sourced from ClinicalTrials.gov (NCT03196167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.