ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-07-03
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05801679

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.

Ages Eligible for Study:21 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject must be an elective or urgent cardiac surgical patient undergoing cardiopulmonary bypass at NorthShore University HealthSystem.
  2. 2. Male or female subject aged 21 to 90 years, at the time of consent.
  3. 3. Subject who can consent in English.
  4. 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. 1. Subjects having emergency cardiac surgery.
  2. 2. Subjects who cannot consent in English.
  3. 3. Subjects who are not eligible to be extubated within 24 hours of the end of surgery.
  4. 4. Subjects with neuromuscular disorders.
  5. 5. Subjects on home oxygen.
  6. 6. Subjects who have known allergies or reactions to rocuronium or sugammadex.
  7. 7. Subjects with anticipated need for prolonged intubation by the clinical treating team.
  8. 8. Subjects with a history of opioid abuse.
  9. 9. Subjects on mechanical circulatory support.
  10. 10. Subjects who have end stage renal disease requiring dialysis.

Contacts and Locations

Principal Investigator

Steven Greenberg, MD
PRINCIPAL_INVESTIGATOR
Endeavor Health

Study Locations (Sites)

NorthShore University HealthSystem
Evanston, Illinois, 60201
United States

Collaborators and Investigators

Sponsor: Endeavor Health

  • Steven Greenberg, MD, PRINCIPAL_INVESTIGATOR, Endeavor Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-03
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-07-03
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • Sugammadex
  • Cardiac Surgical Patients
  • Anesthesia

Additional Relevant MeSH Terms

  • Surgery