Reversal Agents for Postoperative Urinary Retention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether sugammadex or neostigmine, both muscle relaxant reversal agents, more effectively reverses muscle relaxation effects used during surgery. The focus is on adults undergoing surgery lasting at least two hours and requiring muscle relaxation drugs like rocuronium or vecuronium. Participants should be adults having non-heart-related surgery and planning to use one of these reversal agents. This study could enhance recovery after surgery by reducing urinary problems linked to anesthesia. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, seeking to understand how they benefit more patients.
Do I have to stop taking my current medications for this trial?
The trial does not specify if you need to stop all current medications, but you cannot participate if you are currently using anticholinergic medications like antihistamines, phenothiazines, antidepressants, or antipsychotics.
What is the safety track record for these treatments?
Research shows that both neostigmine and sugammadex safely aid muscle recovery after surgery, but they have different effects. Studies have found that neostigmine might make urination more difficult post-surgery. While effective, this issue may occur more frequently than with other treatments. Sugammadex, on the other hand, usually reduces the risk of urination difficulties. Research suggests it significantly lowers this risk compared to neostigmine. Both treatments are generally well-tolerated, but these findings about urination could be important for those considering participation in a clinical trial.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for postoperative urinary retention because they offer potentially faster and more effective reversal of neuromuscular block. Sugammadex is unique because it directly encapsulates the muscle relaxant molecules, quickly reversing their effects, which is different from the traditional cholinesterase inhibitors like neostigmine that work by increasing acetylcholine levels to counteract the block. Additionally, when neostigmine is paired with glycopyrrolate, it helps to reduce unwanted side effects like bradycardia, making it a more balanced option. These approaches promise quicker recovery and fewer complications for patients after surgery.
What evidence suggests that this trial's treatments could be effective for reversing neuromuscular blocks?
This trial will compare the effectiveness of sugammadex and neostigmine in reversing neuromuscular block after surgery. Research has shown that both drugs aid recovery from muscle relaxants. Sugammadex, which participants in this trial may receive, significantly reduces the risk of postoperative urinary retention (POUR). Studies also indicate that sugammadex does not affect other recovery aspects, such as the need to return to the hospital. Neostigmine, another treatment option in this trial, has shown mixed results. It can sometimes increase the risk of POUR, although some studies suggest it might help reduce leftover urine in the bladder. Overall, sugammadex appears more effective at managing urinary issues after surgery.12356
Who Is on the Research Team?
Kurt Ruetzler, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 65 or older who are having noncardiac surgery under general anesthesia with muscle relaxation, and will stay in the hospital overnight. They must be healthy enough (ASA status 1-3) and able to consent. People with urinary issues, severe liver or kidney disease, neurological conditions, or those on certain medications can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Randomized administration of either neostigmine or sugammadex for reversal of neuromuscular block during surgery
Immediate Postoperative Monitoring
Monitoring of twitch responses and urinary retention in the post anesthesia care unit (PACU)
Postoperative Follow-up
Monitoring for urinary retention and other outcomes on the regular ward
Extended Follow-up
Data collection from electronic medical records until postoperative day 4 or discharge
What Are the Treatments Tested in This Trial?
Interventions
- Neostigmine
- Neostigmine with glycopyrrolate
- Sugammadex
Neostigmine is already approved in United States, European Union, India for the following indications:
- Myasthenia Gravis
- Reversal of Neuromuscular Blockade
- Urinary Retention
- Myasthenia Gravis
- Reversal of Nondepolarizing Muscle Relaxants
- Myasthenia Gravis
- Reversal of Neuromuscular Blockade
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor