Sugammadex for Intestinal Obstruction

Overseen By Ryan C Ellis, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Clayton Petro

Must not be taking: Antifungals, HIV protease inhibitors

Disqualifiers: Severe hepatic failure, Severe renal failure, Cancer, 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: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if sugammadex, a medication used to reverse muscle relaxation, can restore normal bowel function faster than the usual treatments, neostigmine/glycopyrrolate, after surgery. It targets patients undergoing open abdominal wall reconstruction, a type of hernia repair surgery. The trial compares two groups: one receiving the standard treatment and the other receiving sugammadex. Ideal participants are those having non-emergency open hernia repairs with specific criteria, such as hernias less than 20 cm wide and no small bowel obstruction. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications that affect liver enzymes, like some antifungals and antibiotics. If you're on these, you might need to stop them to participate.

What is the safety track record for these treatments?

Research has shown that sugammadex, a drug used to aid muscle recovery after surgery, is generally safe. Studies have found that sugammadex reduces the risk of urinary retention post-surgery and helps patients regain muscle function more quickly than other treatments.

However, some risks exist. In rare cases, sugammadex has caused breathing problems requiring surgical intervention. Despite this, its widespread use and approval for other conditions suggest it is generally safe.

Overall, while sugammadex is usually well-tolerated and effective, it can have side effects like any medication. Prospective participants should consult a healthcare provider about potential risks before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for intestinal obstruction that use neostigmine and glycopyrrolate, Sugammadex offers a unique approach. Sugammadex works by directly binding to the muscle relaxant molecules, reversing their effects efficiently. This mechanism allows for potentially faster recovery and fewer side effects compared to the traditional method, which relies on indirectly inhibiting the breakdown of acetylcholine. Researchers are excited about Sugammadex because it promises a quicker and more precise reversal of muscle relaxation, which could improve patient outcomes significantly.

What evidence suggests that sugammadex might be an effective treatment for intestinal obstruction?

Research shows that sugammadex, which participants in this trial may receive, can speed up the return of bowel function after surgery. In studies, patients who received sugammadex had quicker bowel movements, such as passing gas or having a bowel movement, compared to those who took other medications. This suggests sugammadex could help patients recover faster after abdominal surgeries. While it might not reduce the overall hospital stay, it does seem to aid in bowel recovery, which could benefit patients needing quick bowel function return after surgery. Another group in this trial will receive Neostigmine/Glycopyrrolate as the control treatment. ^{2 6 7 8 9}

Who Is on the Research Team?

Clayton C Petro, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 needing non-emergency open ventral hernia repair with specific conditions. Eligible participants should not have severe kidney or liver failure, be at risk of small bowel obstruction as judged by the surgeon, use certain drugs affecting liver enzymes, have a history of chronic opioid use, or disorders that compromise the gastrointestinal lining. Pregnant or breastfeeding individuals and those unable to consent are excluded.

Inclusion Criteria

Non-emergent cases

I am over 18 years old.

My hernia's gap is less than 20cm wide.

Exclusion Criteria

I have a known small bowel obstruction at the time of my hernia repair.

Pregnant or planning to become pregnant during study period

Breastfeeding or planning to breastfeed during study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sugammadex or neostigmine/glycopyrrolate for neuromuscular blockade reversal during open abdominal wall reconstruction

Surgery day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative bowel function, pain, opioid use, and complications

4 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including length of hospital stay and nasogastric tube placement

Up to 1 month

What Are the Treatments Tested in This Trial?

Interventions

• Neostigmine / Glycopyrrolate
• Sugammadex

Trial Overview The study compares sugammadex with standard care (neostigmine/glycopyrrolate) in speeding up the return of bowel function after neuromuscular blockade reversal in abdominal wall reconstruction surgery. It aims to see if sugammadex can improve recovery times for patients undergoing this procedure.

How Is the Trial Designed?

Group I: Sugammadex Experimental Treatment 1 Intervention

Patients randomized to the experimental arm will receive an IV dose of sugammadex according to the package insert of 2 mg/kg for ≥ 2 twitches, 4 mg/kg for 1-2 post-tetanic twitches

Group II: Neostigmine/Glycopyrrolate Experimental Treatment 1 Intervention

Patients assigned to the control arm receive the standardized reversal neostigmine dose with on-label dosing (0.03-0.07mg/kg) and a fixed ratio of glycopyrrolate

Who Is Running the Clinical Trial?

Clayton Petro

Lead Sponsor

Trials

5

Recruited

1,600+

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

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]

In a study involving 10 healthy patients, the combination of glycopyrrolate and neostigmine significantly reduced the barrier pressure of the lower oesophageal sphincter for up to 20 minutes during gynaecological surgery.

This prolonged reduction in barrier pressure contrasts with previous findings using atropine and neostigmine, where the decrease was temporary and returned to baseline within 5 minutes, suggesting that glycopyrrolate may have a more lasting effect on lower oesophageal sphincter function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the combined effects of glycopyrrolate and neostigmine on the lower oesophageal sphincter. Derrington, MC., Hindocha, N., Smith, G.[2019]

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 review of 10 cases of adverse events associated with sugammadex in Korea, serious reactions included five cases of anaphylaxis and one case of cardiac arrest, highlighting the potential risks of this neuromuscular blockade reverser.

The study found that adverse events often occurred shortly after administration, emphasizing the need for continuous monitoring and caution, especially when higher doses of sugammadex are used without adequate neuromuscular recovery assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of sugammadex that occurred in a Korean population. Han, W., Lee, JM., Park, DH., et al.[2022]

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 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]

Sugammadex is an effective agent for quickly reversing neuromuscular block caused by aminosteroidal drugs, offering a faster and more predictable recovery compared to neostigmine, with fewer cholinergic side effects.

Despite its benefits, there are safety concerns regarding potential hypersensitivity reactions and effects on cardiac health, particularly QT interval and clotting times, which require ongoing monitoring and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of sugammadex for reversal of neuromuscular block. Honing, G., Martini, CH., Bom, A., et al.[2019]

Sugammadex is more cost-effective than neostigmine or no reversal agent for reversing rocuronium-induced neuromuscular blockade when considering operating room time valued at $8.60/min or more, making it a preferable choice in many scenarios.

The analysis suggests that sugammadex is particularly beneficial for patients at high risk of unplanned postoperative mechanical ventilation (UPMV), but if OR time costs are not factored in, its routine use may not be justified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sugammadex versus neostigmine for routine reversal of rocuronium block in adult patients: A cost analysis. Hurford, WE., Welge, JA., Eckman, MH.[2021]

In a study of 102 patients undergoing laparoscopic cholecystectomy, the use of sugammadex for neuromuscular blockade reversal resulted in a significantly faster recovery of gastrointestinal motility, with the first passage of flatus occurring on average 5.82 hours earlier than with pyridostigmine and glycopyrrolate.

While sugammadex improved the time to gas-out, it did not significantly affect the time to first defecation or stool types, indicating its specific benefit in enhancing early postoperative gastrointestinal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular blockade reversal with sugammadex versus pyridostigmine/glycopyrrolate in laparoscopic cholecystectomy: a randomized trial of effects on postoperative gastrointestinal motility. An, J., Noh, H., Kim, E., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10179692/

The Postoperative Effect of Sugammadex versus ... Sugammadex reversal resulted in a significantly faster return of defecation or flatus after surgery compared to acetylcholinesterase inhibitors.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2542454819300761

Effects of Sugammadex on Time of First Postoperative ... In comparison with the 2016 and 2017 controls, sugammadex treatment was associated with faster occurrence of first bowel movement. For 2016, unweighted hazard ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-01979-4

Analysis of the association of sugammadex with the length of ... The results of this study revealed that administration of sugammadex did not shorten hospital stay after abdominal surgery. Sugammadex was ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6352235/

Thirty-Day Postoperative Outcomes Following ... The current study revealed that 30-day postoperative outcomes, including total length of hospital stay, length of postoperative hospital stay, ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/72/NCT04546672/Prot_SAP_000.pdf

Sugammadex To IMprove Bowel Function The purpose of this study is to determine if administering sugammadex for reversal of neuromuscular blockade instead of neostigmine and ...

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

The effect of sugammadex on postoperative urinary ... Meta-analysis revealed a significant reduction in the incidence of POUR with sugammadex use (Relative Risk (RR): 0.47, 95% Confidence Interval ( ...

7. mdpi.com mdpi.com/2077-0383/14/12/4128

Sugammadex for Neuromuscular Blockade Reversal A systematic review noted that sugammadex restored spontaneous ventilation in 6 out of 8 cases but led to obstructed breathing requiring surgical intervention ...

8. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01248-2

Economic impact of improving patient safety using ... This economic analysis shows that sugammadex can potentially lead to cost savings for the reversal of rocuronium-induced moderate or profound NMB.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03346057

Safety of Sugammadex for the Reversal of Neuromuscular ... The date on which the study sponsor or investigator first submits a study record with summary results information that is consistent with National Library of ...