Phase 3
N=68
Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT05801679 ↗Enrolled (actual)
68
Serious AEs
4.7%
Results posted
May 2026
Primary outcome: Primary: Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria — 31; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sugammadex (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Endeavor Health
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria |
31; 31 | — |
| SECONDARY Time to First Extubation |
2.80; 3.19 | — |
| SECONDARY Final Train-of-Four Ratio |
1.00; 0.80 | — |
| SECONDARY Final Train-of-Four Ratio |
1.00; 0.80 | — |
| SECONDARY ICU Length of Stay |
2.18; 2.26 | — |
| SECONDARY Hospital Length of Stay |
5.32; 4.42 | — |
| SECONDARY Incidence of Reintubation Post-extubation |
31; 32; 1; 0 | — |
| SECONDARY Incidence of Post-extubation Pneumonia |
30; 31; 2; 1 | — |
| SECONDARY Post-Extubation Hypoxemia |
22; 21; 2; 1; 4; 1 | — |
| SECONDARY Post-Extubation Hypoxemia |
22; 21; 2; 1; 4; 1 | — |
| SECONDARY Nursing Perception Questionnaire of Cardiac Surgical Subjects' ICU Quality of Recovery |
4; 4 | — |
| SECONDARY Final Train-of-Four Ratio Proportion Greater Than or Equal to 0.9 |
32; 12; 0; 20 | — |
Summary
This is a prospective randomized blinded controlled trial that will enroll 175 subjects undergoing cardiopulmonary bypass at NorthShore University HealthSystem. The purpose of this study is to compare clinical outcomes in elective and urgent cardiac surgical patients at NorthShore University HealthSystem when receiving sugammadex, a common neuromuscular blockade reversal drug given after surgery and before the breathing tube is removed vs. those patients who do not receive sugammadex (placebo) group. The Investigators will compare the following outcomes in both the sugammadex and placebo groups during patients hospital stay: # of patients who have the breathing tube removed within 6 hour of the end of surgery, time it takes to remove the breathing tube after surgery, ICU and hospital length of stay, cost of the ICU stay, time to achieve a train of four ratio of > or equal to 0.9, whether patients develop pneumonia or not, whether they require the breathing tube to be replaced during their hospital stay and to compare the nursing perception of patients recovery within first 24 hours of their ICU stay.
Eligibility Criteria
Inclusion Criteria
- Subject must be an elective or urgent cardiac surgical patient undergoing cardiopulmonary bypass at NorthShore University HealthSystem.
- Male or female subject aged 21 to 90 years, at the time of consent.
- Subject who can consent in English.
- Subjects who are eligible for fast track extubation as defined by those patients who plan on being extubated within 24 hours of the end of surgery and optimally within the 6-hour STS benchmark time from end of surgery.
Exclusion Criteria
- Subjects having emergency cardiac surgery.
- Subjects who cannot consent in English.
- Subjects who are not eligible to be extubated within 24 hours of the end of surgery.
- Subjects with neuromuscular disorders.
- Subjects on home oxygen.
- Subjects who have known allergies or reactions to rocuronium or sugammadex.
- Subjects with anticipated need for prolonged intubation by the clinical treating team.
- Subjects with a history of opioid abuse.
- Subjects on mechanical circulatory support.
- Subjects who have end stage renal disease requiring dialysis.
Data sourced from ClinicalTrials.gov (NCT05801679). 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.