Sugammadex vs Neostigmine Reversal for Pediatric Appendectomy

Recruiting in Palo Alto (17 mi)

Overseen by Laura Gilbertson, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Emory University

Disqualifiers: Allergy to Sugammadex, Neostigmine, Renal dysfunction

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is designed as a randomized controlled trial with patients assigned to neuromuscular reversal with either sugammadex or neostigmine/glycopyrrolate reversal. The study will not be blinded to the anesthesiologist to allow for appropriate decision-making on timing and dosage of reversal. This is a single-center study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is sugammadex safe for reversing neuromuscular blockade in pediatric patients?

Research suggests that sugammadex is generally safe for reversing neuromuscular blockade in pediatric patients, with a lower incidence of bradycardia (slow heart rate) compared to neostigmine. No significant differences were found in the incidences of other adverse events. ^{1 2 3 4 5}

How does the drug sugammadex differ from neostigmine for reversing neuromuscular blockade in pediatric appendectomy?

Sugammadex is unique because it works by directly encapsulating and removing the neuromuscular blocking agents rocuronium and vecuronium, leading to a faster and more complete reversal of muscle paralysis compared to neostigmine. Unlike neostigmine, sugammadex does not have cardiovascular, respiratory, or cholinergic side effects, making it a safer option for reversing neuromuscular blockade, especially in pediatric patients. ^{2 5 6 7 8}

Research Team

Laura Gilbertson, MD

Principal Investigator

Emory University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Neostigmine/Glycopyrrolate (Cholinesterase Inhibitor)
• Sugammadex (Selective Relaxant Binding Agent)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Healthcare of Altanta Atlanta, GA

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1735

Patients Recruited

2,605,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

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

Sugammadex versus neostigmine for routine reversal of rocuronium block in adult patients: A cost analysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of sugammadex for reversing postoperative residual neuromuscular blockade in pediatric patients: A systematic review. [2023]

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

Effects of Reversal Technique for Neuromuscular Paralysis on Time to Recovery of Bowel Function after Craniotomy. [2023]

4. England 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. [2018]

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

Clinical Impact of Sugammadex in the Reversal of Neuromuscular Blockade. [2021]

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

Bradycardic Arrest in a Child with Complex Congenital Heart Disease Due to Sugammadex Administration. [2023]

7. India pubmed.ncbi.nlm.nih.gov

Emergency use of sugammadex after failure of standard reversal drugs and postoperative pulmonary complications: A retrospective cohort study. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

A novel approach to reversal of neuromuscular blockade. [2018]