Sugammadex for Cardiac Surgery Outcomes

Recruiting in Palo Alto (17 mi)

Overseen by Steven Greenberg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Endeavor Health

Disqualifiers: Neuromuscular disorders, Home oxygen, Opioid abuse, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug sugammadex for cardiac surgery outcomes?

Research shows that sugammadex can quickly reverse the effects of certain muscle relaxants used during surgery, allowing patients to recover faster. In cardiac surgery, it has been shown to help patients be extubated (have their breathing tube removed) successfully within 6 hours after surgery. ^{1 2 3 4 5}

Is sugammadex safe for use in humans?

Sugammadex is generally considered safe for use in humans, especially in cardiac surgery, with no major clinical side effects reported when used at appropriate doses. However, there have been reports of sugammadex causing bradycardia (slow heart rate), so monitoring is important. ^{2 3 5 6 7}

How does the drug sugammadex differ from other treatments for cardiac surgery outcomes?

Sugammadex is unique because it quickly reverses the effects of certain muscle relaxants used during surgery, like rocuronium and vecuronium, without causing side effects. This can help patients recover faster from anesthesia, potentially reducing the time they need to be on a ventilator after cardiac surgery. ^{2 3 4 5 8}

Research Team

Steven Greenberg, MD

Principal Investigator

Endeavor Health

Eligibility Criteria

This trial is for men and women aged 21-90 undergoing elective or urgent heart surgery with cardiopulmonary bypass at NorthShore University HealthSystem. They must be able to consent in English and be candidates for fast track extubation, which means they're expected to have their breathing tube removed within 24 hours after surgery.

Inclusion Criteria

I am scheduled for heart surgery with cardiopulmonary bypass at NorthShore University.

I am expected to be taken off a ventilator within 24 hours after surgery.

Subject who can consent in English

Exclusion Criteria

Subjects with a history of opioid abuse

I use oxygen at home.

My doctors expect I will need help breathing for a long time.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sugammadex or placebo after cardiac surgery to compare clinical outcomes

Immediate post-surgery

1 visit (in-person)

ICU Monitoring

Participants are monitored in the ICU for extubation criteria and other clinical outcomes

up to 7 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of pneumonia and reintubation

up to 1 week

Treatment Details

Interventions

• Placebo (Other)
• Sugammadex (Neuromuscular Blockade Reversal Agent)

Trial Overview The study compares the effects of Sugammadex, a drug used to reverse muscle relaxation from anesthesia, versus a placebo in patients after cardiac surgery. It will assess how quickly patients can have their breathing tubes removed, length of ICU/hospital stay, costs, pneumonia development, re-intubation rates, and nurse perceptions of recovery.

Participant Groups

Group I: Sugammadex Experimental Treatment 1 Intervention

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).

Group II: Placebo Placebo Group 1 Intervention

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).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NorthShore University HealthSystem Evanston, IL

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Patients Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Patients Recruited

740,000+

Findings from Research

In a study of 60 children undergoing cardiac surgery, sugammadex significantly reduced recovery and extubation times compared to neostigmine, with times of 3.4 minutes and 31.0 minutes respectively, versus 76.2 minutes and 125.2 minutes for neostigmine.

Sugammadex also led to a lower incidence of postoperative atelectasis (0% vs. 20%) and shorter hospital stays (5.8 days vs. 6.5 days), suggesting it is a safer and more effective option for fast-track surgery in pediatric cardiac patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sugammadex for Fast-Track Surgery in Children Undergoing Cardiac Surgery: A Randomized Controlled Study. Li, L., Jiang, Y., Zhang, W.[2022]

A meta-analysis of 40 trials involving 5455 patients found that sugammadex significantly reduces the risk of postoperative nausea and vomiting compared to neostigmine, with a risk ratio of 0.85.

No major complications were reported with sugammadex, and all patients achieved adequate neuromuscular recovery before extubation, indicating its safety and efficacy in the postoperative setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sugammadex versus neostigmine on postoperative nausea and vomiting: a meta-analysis of randomized controlled trials with trial sequential analysis. Hsieh, YL., Lin, CR., Liu, YC., et al.[2023]

In a study of 358 cardiac surgical patients, those who received sugammadex were significantly more likely to be extubated within 6 hours post-surgery (96.67% vs. 81.33%), indicating its potential efficacy in facilitating quicker recovery after surgery.

Patients administered sugammadex also experienced a statistically significant reduction in time to extubation, averaging 3.57 hours compared to 4.72 hours for those who did not receive it, suggesting that sugammadex may enhance recovery times in cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Pilot Comparison Trial Investigating Clinical Outcomes in Cardiac Surgical Patients Who Received Sugammadex Reversal During 2018 to 2021. Greenberg, SB., Ben-Isvy, N., Russell, H., et al.[2023]

In a study of 90 patients undergoing cardiac surgery, the use of sugammadex significantly reduced the time to extubation by about 1 hour compared to a placebo, indicating its efficacy in reversing residual neuromuscular blockade.

No serious adverse events were reported, suggesting that sugammadex is a safe option for facilitating quicker recovery from anesthesia in the post-cardiac surgery ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial. Bardia, A., Treggiari, MM., Dai, F., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Sugammadex for Fast-Track Surgery in Children Undergoing Cardiac Surgery: A Randomized Controlled Study. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

The effect of sugammadex versus neostigmine on postoperative nausea and vomiting: a meta-analysis of randomized controlled trials with trial sequential analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Pilot Comparison Trial Investigating Clinical Outcomes in Cardiac Surgical Patients Who Received Sugammadex Reversal During 2018 to 2021. [2023]

5. India pubmed.ncbi.nlm.nih.gov

Sugammadex--a short review and clinical recommendations for the cardiac anesthesiologist. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Clarifying the grey space of sugammadex induced bradycardia. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Adamgammadex in patients to reverse a moderate rocuronium-induced neuromuscular block. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial. [2023]