Sugammadex for Cardiac Surgery Outcomes

Overseen By Steven Greenberg, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Endeavor Health

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how sugammadex, a drug used to assist in removing the breathing tube after surgery, affects recovery in individuals undergoing heart surgery with a heart-lung machine. Researchers will compare two groups: one receiving sugammadex and the other receiving a placebo (a harmless substance). They seek to discover if sugammadex enables faster recovery, earlier hospital discharge, and reduces complications like pneumonia. The trial seeks participants undergoing planned or urgent heart surgery at NorthShore University HealthSystem who can have their breathing tube removed within 24 hours post-surgery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that sugammadex is likely to be safe for humans?

Research has shown that sugammadex is generally safe, but it does carry some risks. One study found that sugammadex helps patients recover more comfortably after surgery by allowing earlier removal of breathing tubes. However, unexpected and potentially serious side effects, such as rare cases of bradycardia (a slower than normal heart rate), have been reported. Although these side effects are uncommon, they are important to consider when deciding to join a trial. Overall, sugammadex is widely used and usually well-tolerated for reversing muscle relaxants, but like any drug, it carries some risk. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sugammadex is unique because it offers a novel approach to improving outcomes in cardiac surgery by reversing neuromuscular blockade more effectively and rapidly than current options like neostigmine. This treatment stands out due to its ability to encapsulate and inactivate rocuronium or vecuronium molecules, which are commonly used during surgeries, through a process called chelation. Researchers are excited about sugammadex because it can potentially reduce complications and recovery time, making surgery safer and more efficient for patients.

What evidence suggests that sugammadex might be an effective treatment for cardiac surgery outcomes?

In this trial, participants will receive either Sugammadex or a placebo. Research has shown that Sugammadex can significantly improve recovery after heart surgery. One study found that patients who received Sugammadex had their breathing tubes removed about an hour earlier than those who did not, leading to a quicker recovery. Another study found that Sugammadex helped reduce lung issues after surgery. It has also proven safe and effective for reversing muscle relaxation in heart surgery patients. Overall, Sugammadex appears to help patients recover more smoothly after heart surgery. ^{1 5 6 7 8}

Who Is on the Research Team?

Steven Greenberg, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

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.

Subjects who cannot consent in English

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Sugammadex

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.

How Is the Trial Designed?

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).

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Published Research Related to This Trial

Sugammadex is an effective reversal agent for neuromuscular blockade caused by rocuronium and vecuronium, allowing for quick recovery within 5-15 minutes when administered at doses of 2 mg/kg or more.

It is important to monitor neuromuscular transmission before and after administering sugammadex to ensure patient safety and proper extubation, as doses below 2 mg/kg carry a risk of incomplete reversal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sugammadex--a short review and clinical recommendations for the cardiac anesthesiologist. Hemmerling, TM., Zaouter, C., Geldner, G., et al.[2022]

Sugammadex can cause bradycardia in 1 to 7% of cases when reversing neuromuscular blockade, but most instances are not clinically significant and can be easily managed with treatment if needed.

The incidence of severe bradycardia leading to cardiac arrest is very rare with sugammadex, and it is less common than with the traditional reversal agent neostigmine, according to recent studies and FDA reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clarifying the grey space of sugammadex induced bradycardia. Johnson, KB., Chacin, R.[2023]

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]

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]

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 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]

In a study involving 48 surgical patients, adamgammadex significantly reduced the recovery time from rocuronium-induced neuromuscular block, with times dropping from 39.3 minutes in the placebo group to as low as 1.8 minutes in the highest dose group (8 mg/kg).

Adamgammadex was found to be safe and well tolerated, with no serious adverse effects reported, including anaphylactic reactions or prolonged QT intervals, indicating its potential as a reliable reversal agent in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adamgammadex in patients to reverse a moderate rocuronium-induced neuromuscular block. Jiang, YY., Zhang, YJ., Zhu, ZQ., et al.[2022]

In a study involving 116 patients with cardiovascular disease, sugammadex at doses of 2.0 mg/kg and 4.0 mg/kg was found to be safe and effective for reversing rocuronium-induced neuromuscular blockade during noncardiac surgery.

Both doses of sugammadex significantly reduced the time to recovery of muscle function compared to placebo, demonstrating its efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Dahl, V., Pendeville, PE., Hollmann, MW., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9788969/

Efficacy and Safety of Sugammadex to Shorten Time- ... This randomized trial showed that the administration of sugammadex after cardiac surgery decreased time to extubation by approximately 1 hour.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05246397

Sugammadex Titration in Cardiac Surgery Patients The purpose of this observational study is to determine the minimal effective dose of sugammadex by administering 50 mg every 5 minutes until the train-of-four ...

3. jcvaonline.com jcvaonline.com/article/S1053-0770(23)00200-8/abstract

A Retrospective Pilot Comparison Trial Investigating ... This retrospective pilot study compared outcomes in cardiac surgical patients undergoing cardiopulmonary bypass between 2018 to 2021 who ...

4. bjanaesthesia.org bjanaesthesia.org/article/S0007-0912(23)00587-1/fulltext

The effect of sugammadex on patient morbidity and quality ... In conclusion, the use of sugammadex results in a reduction in postoperative pulmonary complications after surgery, but no difference in ...

5. withpower.com withpower.com/trial/phase-3-surgery-4-2023-e74f7?condition=Surgery&overallStatus=Recruiting&hasNoPlacebo=false

Sugammadex for Cardiac Surgery Outcomes In a study involving 116 patients with cardiovascular disease, sugammadex at doses of 2.0 mg/kg and 4.0 mg/kg was found to be safe and effective for reversing ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818024001387

A pharmacovigilance study of FDA adverse events for ... The study identified unexpected and potentially life-threatening AEs associated with sugammadex, a valuable agent for rapidly reversing neuromuscular blockade.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8555093/

A randomized trial evaluating the safety profile of ... In the overall comprehensive evaluation of cardiac safety in the sugammadex development program, bradycardia was infrequently observed [16–20].

8. mdpi.com mdpi.com/2077-0383/14/5/1660

Sugammadex Safely Reduces Total Intubation Time in the ... Previous studies show that sugammadex decreases extubation times, reduces postoperative complications, and enhances patient comfort.