Comparing outcomes in cardiac surgery patients receiving sugammadex versus placebo

A Prospective Randomized Blinded Controlled Trial Comparing Clinical Outcomes in Cardiac Surgical Patients Who Receive Sugammadex vs. Placebo

This study is testing if a drug called sugammadex can help patients recover faster and have fewer complications after heart surgery compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 175 (estimated)
• Ages: 21 Years to 90 Years
• Sex: All
• Sponsor: Endeavor Health (other)
• Locations: 1 site (Evanston, Illinois)
• Trial ID: NCT05801679 on ClinicalTrials.gov

What this trial studies

This prospective randomized blinded controlled trial will enroll 175 subjects undergoing cardiopulmonary bypass at NorthShore University HealthSystem. The study aims to compare clinical outcomes between patients receiving sugammadex, a neuromuscular blockade reversal drug, and those receiving a placebo after cardiac surgery. Key outcomes include the timing of extubation, ICU and hospital length of stay, and the incidence of postoperative complications. The trial seeks to address the potential benefits of reversing neuromuscular blockade to improve recovery times and reduce complications.

Who should consider this trial

Good fit: Ideal candidates are elective or urgent cardiac surgical patients aged 21 to 90 who are eligible for fast track extubation.

Not a fit: Patients requiring emergency cardiac surgery or those with neuromuscular disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery times and reduced complications for cardiac surgery patients.

How similar studies have performed: Previous studies have suggested that reversing neuromuscular blockade can improve outcomes, but this specific approach in cardiac surgery is less well-established.

Eligibility criteria

Inclusion Criteria:

1. Subject must be an elective or urgent cardiac surgical patient undergoing cardiopulmonary bypass at NorthShore University HealthSystem.
2. Male or female subject aged 21 to 90 years, at the time of consent.
3. Subject who can consent in English.
4. 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:

1. Subjects having emergency cardiac surgery.
2. Subjects who cannot consent in English.
3. Subjects who are not eligible to be extubated within 24 hours of the end of surgery.
4. Subjects with neuromuscular disorders.
5. Subjects on home oxygen.
6. Subjects who have known allergies or reactions to rocuronium or sugammadex.
7. Subjects with anticipated need for prolonged intubation by the clinical treating team.
8. Subjects with a history of opioid abuse.
9. Subjects on mechanical circulatory support.
10. Subjects who have end stage renal disease requiring dialysis.

Where this trial is running

Evanston, Illinois

• NorthShore University HealthSystem — Evanston, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Steven Greenberg, MD — Endeavor Health
• Study coordinator: Steven Greenberg, MD

Conditions: Surgery, Sugammadex, Cardiac Surgical Patients, Anesthesia