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Study was terminated due to lack of funding.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | The reversal agent, Sugammadex, will be administered at the start of closure. |
|
| Neostigmine/Glycopyrrolate | Active Comparator | The reversal agent, Neostigmine, will be administered at the start of closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or more. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Time to First Bowel Movement | Time to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital | Up to 48 hours |
| Total Time to Tolerance of an Oral Diet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Gilbertson, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
The research team will share Individual participant data that underlie the results (text, tables, figures, and appendices) reported in the article, after the deidentification
The research team will share the data immediately following publication and ending 3 years following article publication.
Proposals should be directed to laura.gilbertson@emory.edu. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | The reversal agent, Sugammadex, will be administered at the start of closure. Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater. |
| FG001 | Neostigmine/Glycopyrrolate | The reversal agent, Neostigmine, will be administered at the start of closure. Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | The reversal agent, Sugammadex, will be administered at the start of closure. Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater. |
| BG001 | Neostigmine/Glycopyrrolate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | Up to 2 hours |
|
Information on adverse events was collected from the time of consent to participate in the study up to hospital discharge, with an average duration of up to five (5) days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex | The reversal agent, Sugammadex, will be administered at the start of closure. Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Viola Vaccarino, MD, PhD, Principal Investigator | Emory University | 404-727-8710 | lvaccar@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2024 | Aug 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Neostigmine/Glycopyrrolate | Drug | Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present. |
|
|
The research team will evaluate via the Epic computer record after discharge from the hospital
| Up to 24 hours |
| Total Time of Inhalational Anesthesia Exposure | evaluated via the Epic computer record after discharge from the hospital | 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 | 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 | Up to 5 days (depending on length of hospitalization) |
The reversal agent, Neostigmine, will be administered at the start of closure. Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Total Time to First Bowel Movement | Time to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital | Posted | Mean | Standard Deviation | hours | Up to 48 hours |
|
|
|
| Secondary | Total Time to Tolerance of an Oral Diet | The research team will evaluate via the Epic computer record after discharge from the hospital | Posted | Mean | Standard Deviation | hours | Up to 24 hours |
|
|
|
| Secondary | Total Time of Inhalational Anesthesia Exposure | evaluated via the Epic computer record after discharge from the hospital | Posted | Mean | Standard Deviation | minutes | Up to 5 hours (depending on length of surgical procedure) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | minutes | Up to 5 hours (on average depending on post anesthesia recovery) |
|
|
|
| Secondary | Hospital Length of Stay (LoS) | Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital | Posted | Mean | Standard Deviation | hours | Up to 5 days (depending on length of hospitalization) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Neostigmine/Glycopyrrolate | The reversal agent, Neostigmine, will be administered at the start of closure. Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |