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AppendicitisPhase 4NCT05256901

Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy

A Phase 4 study testing Sugammadex and Neostigmine/Glycopyrrolate in people with Appendicitis and Surgery, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Appendicitis, Surgery
What is being tested?
Sugammadex and Neostigmine/Glycopyrrolate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
19 Jul 2023to 5 Aug 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients 2-17 years of age
  • Diagnosis of acute appendicitis
  • Patient undergoing laparoscopic appendectomy at Children's Healthcare of Atlanta- Egleston.
  • Parent or Legal Authorized Representative willing to participate, able to understand and sign an informed consent

Who cannot join

  • Patient with an allergy to Sugammadex or Neostigmine
  • History of renal dysfunction
  • Parent or legal guardian unwilling or unable or unable to understand the informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329

Other trials in United States

About this study

Official title: Effectiveness of Sugammadex Versus Neostigmine on Neuromuscular Reversal in Pediatric Patients Undergoing Laparoscopic Appendectomy for Acute Appendicitis: A Randomized Controlled 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.

Read the detailed description

Patients presenting to the operating room for laparoscopic appendectomy with a diagnosis of acute appendicitis require rapid sequence induction (RSI) due to significant vomiting and concern for increased gastric content. For this reason, succinylcholine-accompanied by neostigmine-is predominantly used in adults for RSI to prevent potential aspiration. Unfortunately, in pediatric patients, there are many concerns about the use of succinylcholine, including complications such as bradycardia, hyperkalemia, dysrhythmias, and cardiac arrest from undiagnosed skeletal muscle myopathy. For many anesthesiologists, these concerns prompted the decision to use a non-depolarizing muscle relaxant such as rocuronium for induction. However, if the standard RSI dose is used, it often results in residual paralysis at the end of short procedures such as laparoscopic appendectomies. It has recently been demonstrated that prolonged paralysis is prevalent even at low doses of rocuronium in pediatric patients. For these reasons, it is imperative to find a way to provide adequate and safe

RSI conditions for intubation, appropriate muscle relaxation for laparoscopic procedures, and the ability to quickly reverse neuromuscular blockade in this pediatric population. Sugammadex has the potential to allow for the utilization of an appropriate RSI dose of rocuronium for intubation, as it provides the ability to reverse neuromuscular blockade earlier than the neostigmine reversal, which is currently the standard of care. 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 effect on operating room efficiency of brief pediatric procedures such as laparoscopic appendectomies, one of the most common urgent pediatric surgeries performed. There are numerous other potential benefits of using sugammadex over typical reversal, including the quicker return of bowel function, faster time to tolerance of an oral diet, and decreased exposure to volatile anesthesia. The return of bowel function is particularly important in pediatric patients undergoing laparoscopic procedures. The research team hypothesizes that the utilization of sugammadex in pediatrics results in a quicker return to bowel function. This has previously been demonstrated in adults, but data are lacking in the pediatric population. Researchers also hypothesize that patients receiving sugammadex versus neostigmine reversal will have an improved time to tolerance of an oral diet, which may impact wound healing and nutrition. As anesthesiologists often underdose rocuronium in these short procedures, due to a lack of quick reversal options, high levels of volatile anesthesia are utilized to compensate for inadequate muscle relaxation. With the use of sugammadex allowing for proper muscle relaxation throughout the entire case, researchers hypothesize that patients will have a lower total volatile anesthetic exposure during the procedure. This is exceedingly important in pediatric anesthesia, where the detrimental effects of volatile anesthetics on the developing brain have been demonstrated in numerous animal studies.

Being tested
Sugammadex, Neostigmine/Glycopyrrolate
Keywords
laparoscopic
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SugammadexDrug

    Also called Intervention Group

    Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or more.

  • Neostigmine/GlycopyrrolateDrug

    Also called Regular Care

    Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.

Study groups in NCT05256901
Study groupRoleWhat they receive
SugammadexExperimentalThe reversal agent, Sugammadex, will be administered at the start of closure.
Receives: Drug: Sugammadex
Neostigmine/GlycopyrrolateActive comparatorThe reversal agent, Neostigmine, will be administered at the start of closure.
Receives: Drug: Neostigmine/Glycopyrrolate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Time From Surgery End to Out of the Operating Room (OR)

    The time from the end of surgery to discharge from the OR will be evaluated via the Epic computer chart after discharge from the hospital.

    Measured: Up to 2 hours

Secondary outcomes (5)
  1. Total Time to First Bowel Movement

    Time to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital

    Measured: Up to 48 hours

  2. Total Time to Tolerance of an Oral Diet

    The research team will evaluate via the Epic computer record after discharge from the hospital

    Measured: Up to 24 hours

  3. Total Time of Inhalational Anesthesia Exposure

    evaluated via the Epic computer record after discharge from the hospital

    Measured: Up to 5 hours (depending on length of surgical procedure)

  4. Length of Stay in the Post-anesthesia Care Unit (PACU)

    PACU length of stay was evaluated via the Epic computer record after discharge from the hospital

    Measured: Up to 5 hours (on average depending on post anesthesia recovery)

  5. Hospital Length of Stay (LoS)

    Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital

    Measured: Up to 5 days (depending on length of hospitalization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start19 Jul 2023
  3. Primary completion5 Jul 2024
  4. Study completion5 Aug 2024

Why it stopped: Study was terminated due to lack of funding.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05256901
Sponsor's protocol ID
STUDY00003913
Status last verified
Sep 2025
First submitted
16 Feb 2022
Last updated
30 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The research team will share Individual participant data that underlie the results (text, tables, figures, and appendices) reported in the article, after the deidentification

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sugammadex and Neostigmine/Glycopyrrolate in people with Appendicitis and Surgery, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Time From Surgery End to Out of the Operating Room (OR) (time frame: Up to 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.

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