Sugammadex for Respiratory Complications
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.12345Why 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.23467
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
Exclusion Criteria
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.
Pathway Design and Implementation
Design and implementation of a clinical best practice pathway to prevent postoperative respiratory complications using clinical decision support.
Prospective Data Collection
Data collection during the implementation of the pathway to monitor the application of best practices and outcomes.
Follow-up
Participants are monitored for safety and effectiveness after pathway implementation.
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?
1
Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
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
Superiority of sugammadex in preventing postoperative ...
This meta-analysis was performed to determine whether sugammadex overmatches neostigmine in reducing postoperative pulmonary complications.
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/s12871-023-02094-0a 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_DysfunctionSugammadex Is Associated With Reduced Pulmonary ...
Recent research has indicated that sugammadex is linked to a decrease in PPCs among patients with respiratory dysfunction undergoing ...
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) ...
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 ...
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 ...
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