Sugammadex vs Neostigmine Reversal for Pediatric Appendectomy

Recruiting at 1 trial location

Overseen By Laura Gilbertson, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Allergy to Sugammadex, Neostigmine, Renal dysfunction

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

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two medications, sugammadex and neostigmine/glycopyrrolate, to aid children's recovery from anesthesia after an appendectomy. The study aims to determine which medication allows for a smoother and quicker wake-up after surgery. Children diagnosed with appendicitis and undergoing laparoscopic appendectomy at Children's Healthcare of Atlanta may qualify for this study. The goal is to improve the recovery process for young patients undergoing this common surgery. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to enhance understanding of their benefits for more 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.

What is the safety track record for these treatments?

Past research has shown sugammadex to be safe for children, effectively reversing muscle relaxants after surgery. A review of 18 studies involving over 1,000 children found that sugammadex worked well without causing serious side effects. However, about 10% of children reported some pain, which is common.

Neostigmine, often used with glycopyrrolate, is also considered safe and has been used for many years to restore muscle strength after surgery. Most children tolerate it well, though some might experience a slower heart rate or increased saliva, effects that are usually mild and manageable.

Both treatments have been used safely in children. Research indicates they are reliable and do not cause major problems. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Sugammadex because it offers a novel way to reverse muscle relaxation in pediatric appendectomy patients. Unlike traditional treatments like Neostigmine, Sugammadex works by encapsulating and inactivating the muscle relaxant directly, which can lead to a faster and more complete recovery. This unique mechanism of action reduces the risk of side effects that are more common with Neostigmine, such as bradycardia and excessive salivation. Sugammadex’s ability to provide a quicker, safer recovery is a significant advancement in postoperative care for children.

What evidence suggests that this trial's treatments could be effective for pediatric appendectomy?

This trial will compare Sugammadex and Neostigmine/Glycopyrrolate as reversal agents for pediatric appendectomy. Research has shown that Sugammadex, which participants in this trial may receive, effectively reverses muscle relaxants used during surgery. Studies have found that it works quickly and safely in both children and adults, helping them wake up from anesthesia faster. Sugammadex can reverse even deep muscle relaxation without major side effects. In contrast, Neostigmine, often used with Glycopyrrolate and another treatment option in this trial, also reverses muscle relaxants but may take longer and have more side effects. Both treatments have been used successfully, but Sugammadex is often preferred for its speed and safety in recovery. ^{3 6 7 8 9}

Who Is on the Research Team?

Laura Gilbertson, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for children aged 2-17 undergoing laparoscopic appendectomy at Children's Healthcare of Atlanta-Egleston, diagnosed with acute appendicitis. Participants need a parent or guardian to understand and sign consent. It excludes those with kidney issues or allergies to Sugammadex or Neostigmine.

Inclusion Criteria

I am between 2 and 17 years old.

I am having my appendix removed at Children's Healthcare of Atlanta-Egleston.

I have been diagnosed with acute appendicitis.

Exclusion Criteria

Patient with an allergy to Sugammadex or Neostigmine

I have had kidney problems in the past.

Parent or legal guardian unwilling or unable to understand the informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo laparoscopic appendectomy with neuromuscular reversal using either sugammadex or neostigmine/glycopyrrolate

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for return of bowel function, tolerance of oral diet, and recovery from anesthesia

Up to 72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 14 days

What Are the Treatments Tested in This Trial?

Interventions

• Neostigmine/Glycopyrrolate
• Sugammadex

Trial Overview The study compares two drugs used after surgery to reverse muscle relaxation: Sugammadex and Neostigmine/Glycopyrrolate. Kids are randomly chosen to receive one of these drugs during an appendectomy in this non-blinded, single-center trial.

How Is the Trial Designed?

Group I: Sugammadex Experimental Treatment 1 Intervention

The reversal agent, Sugammadex, will be administered at the start of closure.

Group II: Neostigmine/Glycopyrrolate Active Control 1 Intervention

The reversal agent, Neostigmine, will be administered at the start of closure.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

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]

Using sugammadex instead of neostigmine for reversing neuromuscular block in the operating room can significantly reduce the risk of residual neuromuscular blockade (RNMB) from 60% to just 4%, preventing complications like hypoxemia and airway obstruction.

In scenarios where full neuromuscular recovery is verified before extubation, sugammadex can improve operating room efficiency by saving an average of 62 minutes per day and reducing staff overtime by 33.5 hours, while also avoiding procedural cancellations due to time overruns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A discrete event simulation model of clinical and operating room efficiency outcomes of sugammadex versus neostigmine for neuromuscular block reversal in Canada. Insinga, RP., Joyal, C., Goyette, A., et al.[2018]

In a study of 1,672 patients undergoing elective surgery, those who received sugammadex after neostigmine had a higher rate of postoperative pulmonary complications (6.8%) compared to those who received sugammadex alone (3.1%).

The findings suggest that using sugammadex as a rescue agent after neostigmine may increase the risk of complications, indicating a need for further investigation into the safety and efficacy of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency use of sugammadex after failure of standard reversal drugs and postoperative pulmonary complications: A retrospective cohort study. Bruceta, M., Singh, PM., Bonavia, A., et al.[2023]

Sugammadex is effective in rapidly reversing neuromuscular blockade caused by rocuronium in pediatric patients, showing a faster recovery time compared to neostigmine or placebo, based on a review of 10 studies with 580 participants.

The use of sugammadex is associated with a lower incidence of bradycardia, indicating a safer profile in terms of adverse events compared to traditional reversal agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of sugammadex for reversing postoperative residual neuromuscular blockade in pediatric patients: A systematic review. Liu, G., Wang, R., Yan, Y., et al.[2023]

In a study of 271 surgical patients, sugammadex was found to have a similar time to extubation compared to the traditional reversal method using neostigmine and glycopyrrolate, with average times of 12.5 minutes and 13.7 minutes respectively, indicating no significant advantage in recovery time.

Despite a higher dosage of sugammadex being used, there were no significant differences in bradycardia incidents or post-anesthesia care unit (PACU) stay times between the two groups, suggesting that while sugammadex is effective, its clinical benefits over neostigmine may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Impact of Sugammadex in the Reversal of Neuromuscular Blockade. Goodner, JA., Likar, EJ., Hoff, AL., et al.[2021]

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]

Sugammadex is a more effective and faster-acting reversal agent for neuromuscular blockade compared to neostigmine, which is important for restoring muscle strength after surgery.

However, in pediatric patients with heart disease, sugammadex can cause significant bradycardia, as demonstrated by a case of a 10-minute bradycardic arrest in an 8-month-old child, highlighting the need for caution in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bradycardic Arrest in a Child with Complex Congenital Heart Disease Due to Sugammadex Administration. Vaswani, ZG., Smith, SM., Zapata, A., et al.[2023]

Sugammadex is a safe and effective agent for reversing neuromuscular blockade caused by rocuronium, with no significant cardiovascular, respiratory, or cholinergic side effects, making it a preferable alternative to neostigmine, especially in patients without neuromuscular monitoring.

It can effectively reverse both shallow and deep neuromuscular blocks and is safe for use in patients with renal impairment, showing no recurrence of neuromuscular blockade, and its effectiveness is not affected by volatile anesthetics like sevoflurane.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to reversal of neuromuscular blockade. Della Rocca, G., Pompei, L.[2018]

Citations

1. trialx.com trialx.com/clinical-trials/listings/245939/sugammadex-vs-neostigmine-reversal-in-pediatric-appendectomy/

Sugammadex vs Neostigmine Reversal in Pediatric ... Retrospective reviews have shown the use of Sugammadex in pediatric patients to be safe and effective. However, there has not been prospective ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05256901?tab=table

Sugammadex vs Neostigmine Reversal in Pediatric ... Retrospective reviews have shown the use of Sugammadex in pediatric patients to be safe and effective. However, there has not been prospective data about the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9575014/

Sugammadex in awakening from general anesthesia The results suggest that sugammadex is as effective in reversing vecuronium or pancuronium-induced NMB as neostigmine, although the time ...

4. anesth-pain-med.org anesth-pain-med.org/journal/view.php?number=1289

Sugammadex for our little ones: a brief narrative review Another study reported rapid recovery without significant side effects when using a fixed dose of 4 mg/kg sugammadex to reverse deep NMB in 34 ...

5. cureus.com cureus.com/articles/104612-successful-neuromuscular-blockade-reversal-using-sugammadex-and-neostigmine-failed-to-prevent-myasthenic-crisis-after-emergency-surgery-a-case-report

Successful Neuromuscular Blockade Reversal Using ... Sugammadex has been demonstrated to provide rapid and complete reversal of NMBAs in patients of varying degrees of NMB. In MG patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9118813/

Efficacy and safety of sugammadex for neuromuscular ... Data from 18 studies involving 1,065 pediatric patients were acquired. The results revealed that use of sugammadex was associated with shorter ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/01/NCT05256901/Prot_SAP_000.pdf

Effectiveness of Sugammadex versus Neostigmine on ... Retrospective reviews have shown the use of Sugammadex in pediatric patients to be safe and effective. However, there has not been ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7360393/

Sugammadex: Applications in Pediatric Critical Care - PMC Furthermore, sugammadex has been shown to be safe and effective in patient populations with contraindications to reversal of neuromuscular blockade with ...

9. merckconnect.com merckconnect.com/bridion/nmb-recovery-pediatric-patients/

Reversal of Neuromuscular Blockade (NMB) in Pediatric ... The most common adverse reactions (reported in ≥ 10% of pediatric patients 2 to <17 years of age at BRIDION doses of 2 or 4 mg/kg) were pain (65% and 61%), ...