Sugammadex for Postoperative Urinary Retention

(POUR Trial)

Overseen By Gregory T Scarola, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Wake Forest University Health Sciences

Disqualifiers: End-stage renal disease, Neuromuscular disease, others

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

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

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

97 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether Sugammadex can help patients urinate more easily after hernia surgery. Sugammadex helps patients wake up from anesthesia faster by reversing muscle relaxants. The study aims to see if it reduces urinary problems and costs without affecting quality of life.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Sugammadex for Postoperative Urinary Retention is an effective drug?

The available research shows that Sugammadex may be effective in reducing the risk of postoperative urinary retention compared to other drugs. For example, one study compared Sugammadex to anticholinesterase and found it to be beneficial in reducing urinary retention after hernia surgery. Another study looked at its use in hysterectomy surgeries and found that Sugammadex was more effective than a combination of glycopyrrolate and neostigmine in preventing urinary retention. These findings suggest that Sugammadex could be a better option for managing this condition after certain surgeries. ^{1 2 3 4 5}

What safety data exists for sugammadex?

Sugammadex is generally considered safe and effective for reversing neuromuscular blockade, but some safety concerns have been reported. These include risks of bronchospasm, coronary arteriospasm, and allergic reactions. There have been case reports of cardiac arrest due to coronary vasospasm after sugammadex administration. Despite these concerns, sugammadex is often preferred over traditional agents like neostigmine due to its rapid and complete reversal of neuromuscular blockade and reduced side effects such as nausea, vomiting, and pulmonary complications. Its safety and efficacy are particularly noted in patients with organ diseases, although hypersensitivity reactions remain a potential risk. ^{6 7 8 9 10}

Is the drug sugammadex a promising treatment for preventing urinary problems after surgery?

Yes, sugammadex is a promising drug for preventing urinary problems after surgery. Studies show that it can reduce the risk of postoperative urinary retention compared to other drugs used for reversing muscle relaxation during surgery. ^{1 2 3 11 12}

Research Team

Brant T Heniford, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 who are having laparoscopic inguinal hernia repair at Carolinas Medical Center and agree to participate. It's not for those with end-stage renal disease, neuromuscular diseases, concurrent major surgeries, or past bad reactions to Sugammadex.

Inclusion Criteria

I am willing to participate in the study.

I am having laparoscopic inguinal hernia repair at Carolinas Medical Center.

I am over 18 years old.

Exclusion Criteria

I am having a hernia repair at the same time as another surgery.

I have a neuromuscular disease.

You have had bad reactions to Sugammadex before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic inguinal hernia repair and receive either Sugammadex or traditional reversal agents

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for urinary retention and other outcomes in the postoperative recovery area

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for quality of life and hospital costs post-surgery

1-2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Sugammadex

Trial Overview The POUR Study is testing whether Sugammadex reduces the rate of urinary retention after surgery compared to traditional reversal agents in patients undergoing laparoscopic inguinal hernia repair.

Participant Groups

Group I: Sugammadex Experimental Treatment 1 Intervention

Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.

Group II: Retrospective cohort Active Control 1 Intervention

Retrospective cohort of patients who did not receive Sugammadex

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

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

Findings from Research

In a study of 3345 patients undergoing inguinal hernia repair, those who received sugammadex for neuromuscular blockade reversal had a significantly lower risk of post-operative urinary retention (POUR) at 1.4%, compared to 4.4% in those treated with anticholinesterase.

Overall, sugammadex was associated with a reduced risk of POUR across various surgical contexts, including open and minimally invasive procedures, as well as unilateral and bilateral repairs, indicating its potential safety advantage in post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of neuromuscular blockade reversal on post-operative urinary retention following inguinal herniorrhaphy. Chau, LC., Jarman, A., Prater, A., et al.[2023]

In a study of 899 patients undergoing lumbar fusion surgery, the use of sugammadex as a reversal agent was found to significantly reduce the risk of postoperative urinary retention (POUR), making it a safer option compared to other agents.

Conversely, the use of succinylcholine during anesthesia was associated with a higher likelihood of developing POUR, with an odds ratio of 4.37, indicating a strong link between this anesthetic agent and urinary retention post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Postoperative Urinary Retention After Lumbar Fusion Surgery: Anesthetics and Surgical Approach. Heard, JC., Lee, Y., Lambrechts, MJ., et al.[2023]

In a study of 485 patients undergoing laparoscopic or robotic hysterectomy, those who received sugammadex had significantly lower odds of experiencing transient postoperative urinary retention (TPOUR) compared to those treated with a combination of glycopyrrolate and neostigmine (GN).

Patients treated with GN were 1.79 times more likely to be discharged with an indwelling catheter, indicating that sugammadex may be a safer option for neuromuscular reversal in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sugammadex on postoperative urinary retention post-laparoscopic and robotic hysterectomy with and without concomitant procedures. Dueñas-Garcia, OF., Shah, T., Fritts, L., et al.[2023]

Neostigmine significantly improves postoperative urinary retention (POUR) compared to traditional Chinese therapies and physical therapy, with a high odds ratio of 7.47 based on a meta-analysis of 20 trials involving 1,850 patients.

Neostigmine acupoint injection is more effective than intramuscular injection, leading to quicker time to first voiding and better urine excretion, indicating a potentially superior method of administration for treating POUR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of neostigmine for urinary retention after surgeries. Cao, M., Wu, X., Xu, J.[2022]

In a study of 78 women with urinary retention after urogynecologic surgery, patient satisfaction was similar whether the indwelling catheter was removed at home or in the office, with median satisfaction scores of 95 in both groups.

However, the home catheter removal group experienced significantly fewer urinary tract infections (8.3%) compared to the office group (26.3%), suggesting a potential safety advantage for home removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of patient satisfaction with home vs office indwelling catheter removal placed for urinary retention after female pelvic floor surgery: a randomized controlled trial. Popiel, P., Swallow, C., Choi, JE., et al.[2023]

Organ diseases can significantly affect how neuromuscular blocking and reversal drugs work, leading to increased risks of complications like prolonged muscle paralysis and side effects from medications.

Sugammadex has been highlighted as a safer option for reversing neuromuscular block in patients with various organ diseases, showing promising efficacy and safety in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular blocking drugs and their antagonists in patients with organ disease. Craig, RG., Hunter, JM.[2018]

Sugammadex is a highly effective and safe reversal agent for neuromuscular blocking agents (NMBAs) like rocuronium, significantly reducing the risk of postoperative residual curarization (PORC), which can lead to serious complications such as hypoxemia and pneumonia.

In rapid sequence intubation, using rocuronium followed by sugammadex is more effective and safer than succinylcholine, suggesting that hospitals should prioritize making sugammadex available to enhance patient safety during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do we need to use sugammadex at the end of a general anesthesia to reverse the action of neuromuscular bloking agents? Position Paper on Sugammadex use. Della Rocca, G., Di Marco, P., Beretta, L., et al.[2018]

A retrospective analysis of the FDA's Adverse Event Reporting System revealed a significant association between sugammadex and bronchospasm, with a reporting odds ratio indicating a strong link (PRR = 71.95).

There is also a notable association between sugammadex and coronary arteriospasm, with a significant disproportionality signal (PRR = 43.82), suggesting that healthcare providers should be cautious and monitor for these adverse events when administering sugammadex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of bronchospasm and coronary arteriospasm with sugammadex use: a post marketing analysis. Aggarwal, P.[2022]

Sugammadex is an effective agent for reversing neuromuscular blockade by encapsulating rocuronium or vecuronium, allowing for rapid recovery even in severe cases, and it has clinical advantages over traditional agents like neostigmine, including fewer side effects such as nausea and pulmonary complications.

While generally safe, there have been reports of anaphylactoid and allergic reactions to sugammadex, highlighting the need for awareness and management strategies for potential hypersensitivity, especially in pediatric cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic Reactions to Sugammadex: A Case Series and Review of the Literature. Banoub, R., Alalade, E., Bryant, J., et al.[2023]

A case study involving a 57-year-old man revealed that administration of 400 mg of sugammadex after cardiac surgery led to sudden ST elevation and cardiac arrest, highlighting a potential risk associated with its use.

Despite the serious complication, the patient recovered fully after treatment for coronary vasospasm, indicating that while sugammadex is generally safe, clinicians should be vigilant about its possible cardiovascular effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac arrest due to coronary vasospasm after sugammadex administration -a case report. Boo, KY., Park, SH., Park, SK., et al.[2023]

A case study highlighted the potential dangers of using oral distigmine bromide for postoperative urinary retention, as it led to a life-threatening 'cholinergic crisis'.

The literature review concluded that the effectiveness of distigmine bromide for this purpose is unproven, suggesting that its use in postoperative urinary retention is not justified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cholinergic crisis following treatment of postoperative urinary retention with distigmine bromide. Hameed, A., Charles, TJ.[2004]

In a study of 61,898 matched adult inpatients and 95,500 matched adult outpatients, patients who received neostigmine with glycopyrrolate for neuromuscular block reversal experienced a two-fold higher incidence of post-operative urinary retention compared to those reversed with sugammadex (5.0% vs 2.4% inpatients; 0.9% vs 0.4% outpatients).

Multivariable analysis confirmed that using neostigmine was independently associated with a greater risk of post-operative urinary retention, with odds ratios of 2.20 for inpatients and 2.57 for outpatients, indicating a significant safety concern with this reversal method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-operative urinary retention is impacted by neuromuscular block reversal agent choice: A retrospective cohort study in US hospital setting. Bash, LD., Turzhitsky, V., Mark, RJ., et al.[2023]

References

1. France pubmed.ncbi.nlm.nih.gov

Effect of neuromuscular blockade reversal on post-operative urinary retention following inguinal herniorrhaphy. [2023]

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

Risk Factors for Postoperative Urinary Retention After Lumbar Fusion Surgery: Anesthetics and Surgical Approach. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The effect of sugammadex on postoperative urinary retention post-laparoscopic and robotic hysterectomy with and without concomitant procedures. [2023]

4. China pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of neostigmine for urinary retention after surgeries. [2022]

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

Assessment of patient satisfaction with home vs office indwelling catheter removal placed for urinary retention after female pelvic floor surgery: a randomized controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Neuromuscular blocking drugs and their antagonists in patients with organ disease. [2018]

7. Italy pubmed.ncbi.nlm.nih.gov

Do we need to use sugammadex at the end of a general anesthesia to reverse the action of neuromuscular bloking agents? Position Paper on Sugammadex use. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Risk of bronchospasm and coronary arteriospasm with sugammadex use: a post marketing analysis. [2022]

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

Allergic Reactions to Sugammadex: A Case Series and Review of the Literature. [2023]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Cardiac arrest due to coronary vasospasm after sugammadex administration -a case report. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Cholinergic crisis following treatment of postoperative urinary retention with distigmine bromide. [2004]

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

Post-operative urinary retention is impacted by neuromuscular block reversal agent choice: A retrospective cohort study in US hospital setting. [2023]