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

April 30, 2026 updated by: Steven Greenberg, Endeavor Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the conclusion of many cardiac surgical cases requiring cardiopulmonary bypass, patients are typically transferred to the intensive care unit (ICU) with the endotracheal tube remaining in the airway postoperatively without routine reversal of neuromuscular blockade (NMB). This blockade is typically metabolized by the liver/kidney and then patients are liberated from the ventilator in the ICU afterwards. The proposed reason for this strategy is to reduce the potential risk of rebleeding or arrhythmias due to a sympathetic response from patients. A survey among 495 cardiac anesthesiologists in the U.S. in 2002 suggested that only 9% of anesthesiologists routinely reverse NMB in these patients prior to extubation. However, the lack of reversal drug use among any surgical patient population could result in residual neuromuscular blockade, which is defined by a train of four ratio ≥0.9. Patients who do not meet this level of neuromuscular recovery are at risk for a number of adverse outcomes including hypoxemia, airway obstruction, impaired swallowing function, increased risk for aspiration, prolonged length of stay, postoperative respiratory complications, and need for reintubation. The data regarding residual neuromuscular blockade in cardiac surgical patients is limited. A prospective observational cohort of 50 cardiac surgical patients, suggested that 66% of patients had significant residual neuromuscular blockade within 1 hour postoperatively. Prolonged intubation can lead to unwanted adverse outcomes such as pneumonia. Our clinical practice at NorthShore University HealthSystem for cardiac surgical patients changed as it relates to managing neuromuscular blockade. Prior to 2019, the clinical care team (cardiac surgery, intensive care, nursing, and anesthesia) did not routinely discuss dosing or reversal of neuromuscular blockade during the ICU handoff of patients. Anesthesia professionals also did not routinely reverse neuromuscular blockade in post-cardiac surgical patients. In the latter half of 2019, the care team developed a multidisciplinary handoff checklist, which includes discussion regarding the last dose of NMB, and whether the patient was given reversal. The anesthesia professionals changed practice to meet or exceed the Society of Thoracic Surgeons (STS) early extubation national benchmark within 6 hours of the end of surgery. Therefore, the investigators hypothesize that by reversing cardiac surgery patients with sugammadex in the ICU, the investigators will be able to achieve the STS early extubation criteria more frequently and it will also result in reduced ICU, hospital length of stay and cost of ICU stay. The investigators also believe it will result in less reintubation and pneumonia.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Healthsystem

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.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugammadex
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Drug: Sugammadex
Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
Other Names:
  • MK-8616
Placebo Comparator: Placebo
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Other: Placebo
Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria
Time Frame: within 6 hours of end of surgery
Will compare the difference in the number of subjects who receive sugammadex and meet the STS 6-hour extubation criteria from the end of surgery vs. those that do not receive neuromuscular blockade reversal. The Society of Thoracic Surgery defines early extubation as extubation within six hours of completion of cardiac surgery and uses this as a reportable benchmark.
within 6 hours of end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Extubation
Time Frame: Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.)
Time to first extubation from end of surgery in each group will be recorded.
Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.)
Final Train-of-Four Ratio
Time Frame: At time of extubation

The final train-of-four ratio was determined at time of extubation using a commercially available quantitative neuromuscular monitor and categorized as greater than or equal to 0.9 or less than 0.9.

In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis.
At time of extubation
Final Train-of-Four Ratio
Time Frame: At time of extubation

The final train-of-four ratio was determined at time of extubation using a commercially available quantitative neuromuscular monitor and categorized as greater than or equal to 0.9 or less than 0.9

In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis.
At time of extubation
ICU Length of Stay
Time Frame: From time of postoperative ICU admission to time of ICU discharge
ICU length of stay (hours) in each group will be recorded.
From time of postoperative ICU admission to time of ICU discharge
Hospital Length of Stay
Time Frame: From time of hospital admission to time of hospital discharge
Hospital length of stay (days) in each group will be recorded.
From time of hospital admission to time of hospital discharge
Incidence of Reintubation Post-extubation
Time Frame: up to 1 week
The incidence of reintubation post-extubation in each group will be collected during the current hospital stay.
up to 1 week
Incidence of Post-extubation Pneumonia
Time Frame: up to 1 week
The incidence of post-extubation pneumonia in each group will be collected during the current hospital stay
up to 1 week
Post-Extubation Hypoxemia
Time Frame: Average of 6 hour intervals over first 24 hours post-operatively
Post-extubation hypoxemic episodes were defined according to the Berlin criteria where PaO2/FiO2 ratios were approximated using previously validated SpO2/FiO2 ratios every 6 hours for 24 hours post-extubation. SpO2/FiO2 < 235 corresponded to moderate to severe hypoxemia and 235-315 corresponded to mild hypoxemia. Reported ratio values were calculated as the average of data collected (every 6 hours) during the 24-hour period post-extubation.
Average of 6 hour intervals over first 24 hours post-operatively
Post-Extubation Hypoxemia
Time Frame: 24 hours post-operatively
Hypoxemia information regarding the first 24 hours post operatively was retrospectively collected post-discharge and was defined in accordance with the Berlin criteria.
24 hours post-operatively
Nursing Perception Questionnaire of Cardiac Surgical Subjects' ICU Quality of Recovery
Time Frame: Within first 24 hours of ICU length of stay

The nursing perception questionnaire of cardiac surgical subjects' ICU quality of recovery within first 24 hours of ICU length of stay will be collected.

(A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4= Somewhat satisfied, 5= Very satisfied)
Within first 24 hours of ICU length of stay
Final Train-of-Four Ratio Proportion Greater Than or Equal to 0.9
Time Frame: At extubation

The number of participants that achieved a qTOFR greater than or equal to 0.9 was compared between the sugammadex and placebo arms.

In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis.
At extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endeavor Health

Investigators

  • Principal Investigator: Steven Greenberg, MD, Endeavor Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Actual)

July 11, 2025

Study Completion (Actual)

July 11, 2025

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH23-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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