Neuromuscular Blockade Agents for Post-Surgery Bowel Recovery

Overseen By Robert R Field, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Irvine

Disqualifiers: Severe valvulopathy, HFrEF, coronary artery disease, autoimmune pulmonary 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: Intraoperative

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, Sugammadex (a neuromuscular blockade reversal agent) and Neostigmine with Glycopyrrolate, to assess their impact on recovery after bowel surgery. Researchers aim to determine which treatment enables a quicker return to normal bowel movements and tolerance of solid food. The trial targets individuals undergoing laparoscopic bowel resection surgery under general anesthesia, with a subsequent hospital stay. As a Phase 4 trial, the treatments have already received FDA approval and proven effective, and this research seeks to understand their benefits for a broader range of patients.

Will I have to stop taking my current medications?

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 these treatments?

Research has shown that both Neostigmine and Sugammadex have undergone safety testing in people. Neostigmine, in small doses, aids gut recovery after surgery without major side effects and often reverses muscle relaxants post-surgery.

Studies have also shown that Sugammadex speeds up bowel recovery after surgery and is linked to less nausea, vomiting, and urinary issues. However, some patients still experience nausea and vomiting with Sugammadex.

Both treatments are generally well-tolerated and assist in recovery after surgery. This evidence suggests that Neostigmine and Sugammadex are safe options with manageable side effects for patients undergoing colorectal surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer innovative approaches to enhancing bowel recovery after surgery. Unlike traditional methods that rely on standard neuromuscular blockers, Neostigmine and Sugammadex work differently. Neostigmine, combined with glycopyrrolate, helps reverse muscle relaxation by increasing acetylcholine, which stimulates bowel movement. Sugammadex, on the other hand, uniquely binds to and inactivates specific muscle relaxants, potentially allowing for quicker and more precise reversal of muscle paralysis. These mechanisms offer a promising alternative to standard treatments, which could lead to faster recovery times for patients.

What evidence suggests that this trial's treatments could be effective for post-surgery bowel recovery?

In this trial, participants will receive either Neostigmine with Glycopyrrolate or Sugammadex to aid in bowel recovery after surgery. Research has shown that Neostigmine with Glycopyrrolate may moderately improve bowel function and relieve certain bowel blockages, though its effectiveness can vary. Sugammadex, on the other hand, has shown more promising results. Studies indicate it helps bowel function return faster and reduces delays in bowel movements after surgery. It is also linked to less nausea and vomiting. Overall, Sugammadex seems to offer a quicker recovery for bowel function compared to traditional treatments. ^{1 6 7 8 9}

Who Is on the Research Team?

Robert R Field, MD

Principal Investigator

Associate Clinical Professor

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having laparoscopic bowel resection surgery and will stay in the hospital afterwards. They must be using specific muscle relaxants during surgery and can't have certain heart, lung or kidney conditions, an ostomy after surgery, or be pregnant. Also, they shouldn't be allergic to the drugs being tested.

Inclusion Criteria

I am having a laparoscopic surgery on my bowel that requires staying in the hospital.

Exclusion Criteria

My heart pumps blood normally.

I am unable to understand or consent to the research project.

I have had surgery to remove part of my bowel and now have an ostomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bowel resection surgery with neuromuscular blockade and reversal using either Sugammadex or Neostigmine with Glycopyrrolate

Intraoperative

1 visit (in-person)

Postoperative Recovery

Participants are monitored for GI-2 recovery, including time to first bowel movement and tolerance for solid food

Up to 24 hours post surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including morbidity and mortality rate

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Neostigmine
• Sugammadex

Trial Overview The study compares two drugs used to reverse muscle relaxation from anesthesia: Sugammadex and Neostigmine with Glycopyrrolate. It looks at how quickly patients have their first bowel movement and tolerate solid food after bowel resection surgery.

How Is the Trial Designed?

Group I: Neostigmine plus Glycopyrrolate Active Control 1 Intervention

0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate 2 syringes numbered 1 and 2 1. Syringe #1: Glycopyrrolate 2. Syringe #2: Neostigmine

Group II: Sugammadex Active Control 1 Intervention

2.0 mg/kg of Sugammadex plus saline equivalent 2 syringes numbered 1 and 2 1. Syringe #1: 0.9% sodium chloride 2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

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 65,702 patients who underwent non-cardiac surgery, those who received sugammadex to reverse neuromuscular blockade had a 40% lower risk of 90-day mortality compared to those who received neostigmine, suggesting sugammadex may improve postoperative outcomes.

The findings indicate that sugammadex could be a safer option for reversing neuromuscular blockade, but the study's retrospective nature means further research with direct neuromuscular function monitoring is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of neuromuscular reversal by sugammadex and neostigmine with 90-day mortality after non-cardiac surgery. Oh, TK., Ryu, JH., Nam, S., et al.[2021]

Sugammadex appears to have more tolerable effects on kidney function compared to neostigmine in patients undergoing elective surgery, as indicated by differences in postoperative kidney markers like cystatin C.

Both sugammadex and neostigmine do not cause renal failure, but they can negatively affect kidney function, highlighting the importance of monitoring kidney health during and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sugammadex and Neostigmine on Renal Biomarkers. Isik, Y., Palabiyik, O., Cegin, BM., et al.[2019]

In a study comparing two methods of reversing neuromuscular blockade in patients undergoing intraperitoneal surgery, those treated with sugammadex experienced their first postoperative bowel movement significantly earlier than those treated with neostigmine/glycopyrrolate, with hazard ratios indicating a 27% to 51% faster occurrence depending on the year of the study.

The analysis included 4,833 patients across two years, and results were consistent even after adjusting for potential biases, highlighting the efficacy of sugammadex in improving postoperative recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sugammadex on Time of First Postoperative Bowel Movement: A Retrospective Analysis. Deljou, A., Schroeder, DR., Ballinger, BA., et al.[2022]

In a study of 98 patients undergoing surgery, sugammadex was associated with a significantly lower incidence of postoperative nausea and vomiting (PONV) in the first hour compared to neostigmine, with only 8% of patients in the sugammadex group experiencing nausea or vomiting versus 27% in the neostigmine group.

Over a 24-hour monitoring period, patients who received sugammadex required significantly fewer anti-emetic treatments (ondansetron) compared to those who received neostigmine, indicating that sugammadex may be a safer option for minimizing PONV after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of the effects of sugammadex and neostigmine on postoperative nausea and vomiting]. Yağan, Ö., Taş, N., Mutlu, T., et al.[2019]

Sugammadex is preferred over neostigmine for reversing neuromuscular blockade due to its beneficial pharmacokinetics and perceived superior efficacy, as identified in a review of 100 surgical cases involving 42 anesthesia providers.

Anesthesia providers cited concerns about the adverse effects of neostigmine and the desire for more predictable patient responses as key reasons for choosing sugammadex, highlighting its limited adverse effect profile and reduced risk of residual neuromuscular blockade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Indications for the Use of Sugammadex After Its Addition to a Formulary at a Tertiary Care Children's Hospital. Barry, N., Uffman, JC., Tumin, D., et al.[2022]

In a study of 60 pediatric patients aged 2-10 years, sugammadex led to significantly faster recovery and extubation times compared to neostigmine, with recovery times of 2.5 minutes for sugammadex versus 12.6 minutes for neostigmine.

Sugammadex also resulted in fewer patients needing additional doses to achieve recovery, with only 1 patient requiring another dose compared to 8 patients in the neostigmine group, and it had a lower incidence of adverse effects like nausea and tachycardia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of sugammadex and neostigmine for reversal of rocuronium-induced neuromuscular blockade in children. Ammar, AS., Mahmoud, KM., Kasemy, ZA.[2018]

In a study of 731 patients undergoing craniotomy, those who received sugammadex to reverse neuromuscular blockade experienced earlier recovery of bowel function, with a higher likelihood of having their first bowel movement within 24 and 48 hours compared to those treated with neostigmine/glycopyrrolate.

Statistical analyses indicated that sugammadex was associated with improved bowel function recovery, suggesting it may be a more effective option for reversing neuromuscular blockade in terms of postoperative gastrointestinal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Reversal Technique for Neuromuscular Paralysis on Time to Recovery of Bowel Function after Craniotomy. Deljou, A., Soleimani, J., Sprung, J., et al.[2023]

In a study of 98 patients undergoing surgery, sugammadex was associated with a significantly lower incidence of postoperative nausea and vomiting (PONV) in the first hour compared to neostigmine, with only 8% of patients in the sugammadex group experiencing nausea/vomiting versus 27% in the neostigmine group.

Patients receiving sugammadex also required fewer anti-emetic medications (ondansetron) for PONV treatment over 24 hours, indicating that sugammadex may be a safer option for minimizing PONV after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of sugammadex and neostigmine on postoperative nausea and vomiting. Yağan, Ö., Taş, N., Mutlu, T., et al.[2018]

Sugammadex, when used for reversing neuromuscular blockade, resulted in faster recovery times for extubation, first eye opening, and head lift compared to neostigmine, indicating its efficacy in enhancing recovery after anesthesia.

While sugammadex showed lower postoperative nausea and vomiting (PONV) scores immediately after surgery, the overall reduction in PONV was only slight and temporary compared to neostigmine, suggesting that while it may help, it is not a definitive solution for PONV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of sugammadex and conventional reversal on postoperative nausea and vomiting: a randomized, blinded trial. Koyuncu, O., Turhanoglu, S., Ozbakis Akkurt, C., et al.[2018]

In a study of 68 morbidly obese patients undergoing bariatric surgery, sugammadex (SM) was found to significantly reduce the time to extubation and recovery compared to neostigmine (NT), indicating its efficacy in reversing neuromuscular block more effectively.

Both SM and NT showed similar safety profiles, with no significant differences in adverse effects such as respiratory difficulties or hemodynamic changes, suggesting that SM may be a safer option for this high-risk patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neostigmine versus sugammadex on post-operative recovery following bariatric surgery. Ekinci, O., Gulmez, DD., Subasi, FD., et al.[2022]

Citations

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Neostigmine - StatPearls - NCBI Bookshelf - NIH This medication is primarily used to reverse nondepolarizing neuromuscular blockade after surgery via slow intravenous injection and for ...

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Neuromuscular Blockade Comparison for GI-2 Recovery ... Currently, there is little available prospective outcomes data regarding the use of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as ...