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.
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
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.
- Conditions
- Appendicitis, Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | The reversal agent, Sugammadex, will be administered at the start of closure. Receives: Drug: Sugammadex |
| Neostigmine/Glycopyrrolate | Active comparator | The 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.
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)
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
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
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)
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)
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.
- First posted25 Feb 2022
- Study start19 Jul 2023
- Primary completion5 Jul 2024
- Study completion5 Aug 2024
Why it stopped: Study was terminated due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Gilbertson, Emory University
- Investigators
- Laura Gilbertson, MD, Principal investigator, Emory University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sugammadex Versus Neostigmine on Neuromuscular Reversal in Pediatric Patients Undergoing Laparoscopic Appendectomy for Acute Appendicitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05256901
- Acronym / sponsor ID
- STUDY00003913
- Conditions
- Appendicitis, Surgery
- Keywords
- laparoscopic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of funding.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Posted 30 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Experimental | Drug: SugammadexThe reversal agent, Sugammadex, will be administered at the start of closure. |
| Neostigmine/Glycopyrrolate | Active comparator | Drug: Neostigmine/GlycopyrrolateThe reversal agent, Neostigmine, will be administered at the start of closure. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: Intervention GroupParticipants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or more. | Drug | Sugammadex |
| Neostigmine/GlycopyrrolateAlso: Regular CareParticipants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present. | Drug | Neostigmine/Glycopyrrolate |
Primary outcome
Total Time From Surgery End to Out of the Operating Room (OR)
Time frame: Up to 2 hours
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.
5 secondary outcomes
Total Time to First Bowel Movement
Time frame: Up to 48 hours
Total Time to Tolerance of an Oral Diet
Time frame: Up to 24 hours
Total Time of Inhalational Anesthesia Exposure
Time frame: Up to 5 hours (depending on length of surgical procedure)
Length of Stay in the Post-anesthesia Care Unit (PACU)
Time frame: Up to 5 hours (on average depending on post anesthesia recovery)
Hospital Length of Stay (LoS)
Time frame: Up to 5 days (depending on length of hospitalization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Gilbertson, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
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.