Sugammadex for Respiratory Complications

Overseen By Stephanie-Dee Sarovich, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Los Angeles

Must be taking: Sugammadex

Disqualifiers: Age under 18, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how sugammadex, a medication, affects breathing problems after surgery. Researchers are examining past patient data to determine if sugammadex alleviates post-surgery breathing issues, particularly in individuals with conditions like sleep apnea or other respiratory problems. The trial will also develop guidelines for doctors to enhance care for these high-risk patients. Individuals who underwent surgery with specific anesthesia drugs and received sugammadex might be suitable candidates for this trial. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

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 is the safety track record for sugammadex?

Studies have shown that sugammadex is generally well-tolerated and can help reduce certain lung problems after surgery. Research indicates that sugammadex is more effective than neostigmine in lowering the risk of lung issues like pneumonia and the need for breathing support post-surgery.

However, some evidence suggests that sugammadex might increase the chances of these complications in certain cases. One study found that patients had a 44% higher chance of experiencing lung problems compared to other treatments, although this result wasn't consistent across all research.

Overall, the FDA has approved sugammadex for reversing certain muscle relaxants used during surgery, indicating its safety for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sugammadex for respiratory complications because it offers a unique approach to reversing neuromuscular blockade, especially in patients with respiratory diseases or obstructive sleep apnea (OSA). Unlike traditional options like neostigmine, sugammadex directly encapsulates and inactivates the muscle relaxant rocuronium, leading to a faster and more reliable recovery of muscle function. This targeted mechanism reduces the risk of residual paralysis and potential respiratory issues post-surgery, making it a promising option for high-risk patients who require general anesthesia.

What is the effectiveness track record for sugammadex in preventing postoperative respiratory complications?

Studies have shown that sugammadex significantly lowers the risk of lung problems after surgery compared to treatments like neostigmine. One analysis found that sugammadex reduced the chances of issues such as pneumonia and the need for assisted breathing after surgery. Another study showed that patients using sugammadex experienced fewer lung problems than those who did not. In this trial, researchers are evaluating sugammadex as part of a comprehensive pathway for managing pulmonary complications in high-risk surgical patients. This treatment has already proven effective for managing breathing issues in surgical patients, especially those with pre-existing breathing difficulties. Overall, sugammadex appears to be a strong choice for preventing lung-related problems after surgery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adult patients at UCLA hospitals who've had general anesthesia with specific muscle relaxants and received sugammadex. It excludes those under 18, with neuromuscular diseases, known drug allergies, severe kidney issues or who remained intubated after surgery.

Inclusion Criteria

People 18 years or older who had surgery at UCLA Ronald Reagan or Santa Monica and were given a certain type of anesthesia.

You have been given sugammadex from the study's designated supply.

Exclusion Criteria

You are still using a breathing tube or have a tracheostomy after surgery.

You have a known neuromuscular disease.

Patients under the age of 18

Timeline for a Trial Participant

Retrospective Data Analysis

Analysis of data from the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction before and after the introduction of sugammadex.

6 months

Pathway Design and Implementation

Design and implementation of a clinical best practice pathway to prevent postoperative respiratory complications using clinical decision support.

6 months

Prospective Data Collection

Data collection during the implementation of the pathway to monitor the application of best practices and outcomes.

1 year

Follow-up

Participants are monitored for safety and effectiveness after pathway implementation.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Sugammadex

Trial Overview The study analyzes past data to see if respiratory problems in the recovery room decreased after sugammadex was used. It also tests a new best practice pathway using education and decision support to prevent breathing complications in high-risk patients.

How Is the Trial Designed?

Group I: CDS pathway Experimental Treatment 1 Intervention

When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10325761/

Superiority of sugammadex in preventing postoperative ... This meta-analysis was performed to determine whether sugammadex overmatches neostigmine in reducing postoperative pulmonary complications.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10767056/

Effect of sugammadex on postoperative complications in ... The postoperative pulmonary complications risk was reduced significantly in patients who use sugammadex than those who did not use sugammadex. ( ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02094-0

a systematic review and meta-analysis with trial sequential ... We concluded that sugammadex is more effective at reducing the incidence of PPCs including pneumonia, atelectasis, NIV and reintubation compared with ...

4. researchgate.net researchgate.net/publication/371275415_Sugammadex_Is_Associated_With_Reduced_Pulmonary_Complications_in_Patients_With_Respiratory_Dysfunction

Sugammadex Is Associated With Reduced Pulmonary ... Recent research has indicated that sugammadex is linked to a decrease in PPCs among patients with respiratory dysfunction undergoing ...

5. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(25)00113-8/fulltext

Pulmonary complications associated with sugammadex or ... Sugammadex was associated with higher odds of experiencing the primary outcome of PPCs (odds ratio [OR]: 1.44; 95% confidence interval [CI]: 1.02–2.05; P=0.038) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10116764/

Postoperative pulmonary complications after sugammadex ... We concluded that sugammadex is more effective at reducing the incidence of PPCs including pneumonia, atelectasis, NIV and reintubation compared with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04263363?tab=history&a=8

Record History | ver. 8: 2025-07-09 | NCT04263363 The date on which the study sponsor or investigator first submits a study record with summary results information that is consistent with National Library of ...