Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo

Description

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.

Conditions

Surgery

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Study Details

Study overview

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.

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

Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo

Condition
Surgery
Intervention / Treatment

-

Contacts and Locations

Evanston

NorthShore University HealthSystem, Evanston, Illinois, United States, 60201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

21 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NorthShore University HealthSystem,

Steven Greenberg, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

2025-06