Sugammadex vs Neostigmine/Glycopyrrolate for Urinary Retention After Spinal Surgery

Overseen By Boris Mraovic, MD, FASA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Missouri-Columbia

Must not be taking: Urological medications, Diuretics

Disqualifiers: Neuromuscular disorders, Renal disease, Liver 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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, sugammadex and a combination of neostigmine and glycopyrrolate, to determine which better prevents urinary retention (difficulty urinating) after spinal surgeries. Participants will receive one of these treatments to reverse muscle relaxation caused by anesthesia drugs during surgery. Ideal participants are adults scheduled for elective spine surgery who have no history of urinary issues and do not take medications affecting urination. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently prescribed urological medications or diuretics, you may not be eligible to participate.

What is the safety track record for these treatments?

Research shows that sugammadex is generally safe for patients. Studies have found that it greatly lowers the chances of postoperative urinary retention (POUR). In simpler terms, fewer people have difficulty urinating after surgery when they receive sugammadex. These studies have not reported any major harmful side effects from sugammadex.

Neostigmine combined with glycopyrrolate is another option to reverse muscle relaxation after surgery. However, visits for urinary problems were five times higher in patients who received neostigmine compared to those who received sugammadex. This suggests that neostigmine might not be as effective in preventing urinary issues after surgery.

Both treatments are generally considered safe, but sugammadex seems to be better at reducing urinary problems post-surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Sugammadex because it offers a unique approach to addressing urinary retention after spinal surgery. Unlike the standard treatment with Neostigmine/Glycopyrrolate, which works by inhibiting the breakdown of acetylcholine to reverse muscle paralysis, Sugammadex directly binds to and inactivates the muscle relaxants themselves. This novel mechanism allows for a potentially quicker and more efficient reversal of muscle relaxation, which may reduce the risk of urinary retention and improve recovery times.

What evidence suggests that this trial's treatments could be effective for urinary retention after spinal surgery?

In this trial, participants will receive either Sugammadex or Neostigmine with Glycopyrrolate to assess their effectiveness in preventing post-operative urinary retention (POUR) after spinal surgery. Research has shown that Sugammadex can greatly reduce the chances of urinary difficulties after surgery. Specifically, studies have found that patients are less likely to experience this issue when treated with Sugammadex compared to other treatments. Sugammadex aids in easier urination post-surgery. In contrast, Neostigmine with Glycopyrrolate is less effective in preventing urinary problems. Sugammadex has already proven effective for other conditions, suggesting it could also help with urinary issues after spinal surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Boris Mraovic, MD, FASA

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

Adults aged 18 or older, with a physical status classified as ASA I-III, who are undergoing elective ambulatory spine surgery can join. Excluded are those with allergies to study drugs, neuromuscular disorders, severe kidney/liver disease, recent genitourinary procedures or cancer treatments, BPH symptoms, urinary issues or on related meds.

Inclusion Criteria

My health is good to moderately impaired.

Exclusion Criteria

I am currently taking medication for bladder problems or water pills.

I have had surgery or treatment for urinary or genital issues, including cancer, in the past year.

I have a diagnosed or suspected muscle or nerve disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Sugammadex or Neostigmine/glycopyrrolate for reversal of rocuronium after spine surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for urinary retention and other outcomes postoperatively

7 days

Daily monitoring during hospital stay

What Are the Treatments Tested in This Trial?

Interventions

• Neostigmine/Glycopyrrolate
• Sugammadex

Trial Overview The trial is testing if Sugammadex is better than Neostigmine/Glycopyrrolate at preventing urinary retention after spine surgery when reversing the effects of Rocuronium—anesthesia-related muscle relaxation.

How Is the Trial Designed?

Group I: Sugammadex 2 mg/kg Experimental Treatment 2 Interventions

Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.

Group II: Neostigmine + Glycopyrrolate Active Control 3 Interventions

Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

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

Published Research Related to This Trial

In a study of 1,974 patients undergoing hysterectomy, the use of sugammadex for reversing neuromuscular blockade was associated with a significantly lower risk of postoperative urinary retention (POUR) compared to neostigmine-glycopyrrolate, with an odds ratio of 0.53.

The findings suggest that the lower risk of POUR with sugammadex may be due to the absence of glycopyrrolate, which is used with neostigmine and may contribute to urinary retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sugammadex and urinary retention after hysterectomy: A propensity-matched cohort study. De Lima Laporta Miranda, ML., Ochs Kinney, MA., Bakkum-Gamez, JN., 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 181 patients undergoing unilateral inguinal herniorrhaphy, reversal of neuromuscular blockade with sugammadex was associated with significantly lower rates of postoperative urinary retention (POUR) compared to neostigmine/glycopyrrolate, with only 3% of patients in the sugammadex group experiencing POUR versus 15% in the neostigmine/glycopyrrolate group.

The findings suggest that using sugammadex may be a safer option for preventing POUR, which can lead to complications such as unplanned admissions or emergency room visits, although further confirmation through randomized studies is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary Retention Following Inguinal Herniorrhaphy: Role of Neuromuscular Blockade Reversal. Valencia Morales, DJ., Stewart, BR., Heller, SF., et al.[2023]

Glycopyrrolate, commonly used with neostigmine to reverse non-depolarizing neuromuscular blockade, has been associated with adverse effects on the genitourinary system, particularly increasing the risk of urinary retention.

This review aims to update the understanding of glycopyrrolate's impact on post-operative urinary retention, addressing gaps in previous studies that did not prioritize this outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycopyrrolate and Post-Operative Urinary Retention: A Narrative Review. Low, J., Escobar, M., Baquero, S., et al.[2020]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12466067/

The effect of sugammadex on postoperative urinary ... These findings suggest that sugammadex substantially reduces POUR incidence, with no significant impact on POPS or 30-day readmission rates.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0952818023002945

Post-operative urinary retention is impacted by ... Single-institution studies have found decreased incidence of post-operative urinary retention associated with sugammadex reversal. This study used a multicenter ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839741

Sugammadex for Postoperative Urinary Retention in ... In this study, the use of sugammadex in MIS-IHR was associated with a significant reduction in POUR and LOS. While limited by sample size, no ...

4. jheor.org jheor.org/article/121641-economic-impact-of-postoperative-urinary-retention-in-the-us-hospital-setting

Economic Impact of Postoperative Urinary Retention in the ... Furthermore, results from a randomized controlled trial to evaluate efficacy of sugammadex vs neostigmine reported urinary retention only in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05887375

Sugammadex vs Neostigmine/Glycopyrrolate on Urinary ... This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05887375

Sugammadex vs Neostigmine/Glycopyrrolate on Urinary ... This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the ...

7. apsf.org apsf.org/in-the-literature/post-operative-urinary-retention/

Summary of "Post-operative urinary retention is impacted ... POUR-related visits within 2 days following discharge were five-fold higher among those reversed with neostigmine than sugammadex among ...