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

118 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory spine surgery.

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 data supports the effectiveness of the drug sugammadex compared to neostigmine/glycopyrrolate for reducing urinary retention after surgery?

Research shows that sugammadex is associated with a lower risk of postoperative urinary retention compared to neostigmine/glycopyrrolate, with a study finding a 24.8% incidence of urinary retention with neostigmine-glycopyrrolate versus 18.3% with sugammadex. ^{1 2 3 4 5}

Is sugammadex generally safe for humans compared to neostigmine/glycopyrrolate?

Sugammadex is generally considered safe and may have a lower risk of causing urinary retention after surgery compared to neostigmine/glycopyrrolate. Studies show that sugammadex is associated with a lower incidence of postoperative urinary retention and similar effects on bladder discomfort compared to other reversal agents. ^{1 2 3 5 6}

How does the drug sugammadex differ from neostigmine/glycopyrrolate for preventing urinary retention after spinal surgery?

Sugammadex is unique because it is associated with a lower risk of postoperative urinary retention compared to the combination of neostigmine and glycopyrrolate. This is likely due to sugammadex's different mechanism of action, which does not involve the anticholinergic effects of glycopyrrolate that can inhibit bladder contraction. ^{1 2 3 4 5}

Research Team

Boris Mraovic, MD, FASA

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

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]

References

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

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

2. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Sugammadex and urinary retention after hysterectomy: A propensity-matched cohort study. [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. United States pubmed.ncbi.nlm.nih.gov

Urinary Retention Following Inguinal Herniorrhaphy: Role of Neuromuscular Blockade Reversal. [2023]

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

Glycopyrrolate and Post-Operative Urinary Retention: A Narrative Review. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the Effect of Sugammadex and Pyridostigmine on Postoperative Catheter-Related Bladder Discomfort: A Retrospective Matched Cohort Analysis. [2022]