A Phase 4 interventional study of Neostigmine / Glycopyrrolate and Sugammadex in Hernia, Ventral and Ileus, sponsored by Clayton Petro. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Clayton Petro · Phase 4, Interventional, and Supportive care
The aim of the study is to determine if the usage of sugammadex would reduce the time to return of bowel function when compared to standard of care (neostigmine/glycopyrrolate) when used for neuromuscular blockade reversal in patients with open abdominal wall reconstruction (AWR).
The investigators baseline postoperative ileus (POI) rate in the setting of open abdominal wall reconstruction (AWR) is similar to patients undergoing an open bowel resection and often prolongs patients' hospital stay. Therefore, the investigators aim to determine whether the use of sugammadex has a clinically significant impact on return of postoperative bowel function and prevention of POI in these patients.
The primary outcome is GI-2: postoperative time until passage of 1st bowel movement and tolerance of solid food.
The investigators hypothesize:
Specific Aim 1: To determine if the use of sugammadex for neuromuscular blockade reversal reduces the time to postoperative GI-2 bowel function compared to neostigmine/glycopyrrolate for neuromuscular blockade reversal.
Specific Aim 2: To determine if sugammadex reduces the incidence of postoperative NG placement compared to neostigmine/glycopyrrolate for neuromuscular blockade reversal.
Specific Aim 3: To determine if sugammadex reduces postoperative length of stay following AWR compared to neostigmine/glycopyrrolate for neuromuscular blockade reversal.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's enrollment of 184 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Clayton Petro is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients assigned to the control arm receive the standardized reversal neostigmine dose with on-label dosing (0.03-0.07mg/kg) and a fixed ratio of glycopyrrolate
Drug: Neostigmine / Glycopyrrolate
Patients randomized to the experimental arm will receive an IV dose of sugammadex according to the package insert of 2 mg/kg for ≥ 2 twitches, 4 mg/kg for 1-2 post-tetanic twitches
Drug: Sugammadex
Drug pages: Neostigmine · Glycopyrrolate
Patients will receive standard of care for reversal of neuromuscular blockade
Also known as: Control arm
Patients will receive sugammadex for reversal of neuromuscular blockade
Also known as: Experimental arm
Time to GI-2 bowel function after surgery
The median time to first postoperative bowel movement and tolerance of solid food (defined as GastroIntestinal-2), as measured in hours, will be recorded for each patient and compared between the two groups.
Time frame: From time of randomization to progression of bowel function, which is an average of 87 hours, or until 1 month after randomization; whichever comes first
Length of stay
Duration of hospital stay as measured in hours from end of surgery to placement of discharge order will be
Time frame: From time of randomization to progression allowing safe discharge home, which is an average of 6 days, or until 1 month after randomization; whichever comes first
Postoperative nasogastric tube placement rate
Placement of nasogastric tube for nausea/vomiting after surgery will be recorded and compared between the two groups.
Time frame: Up to 1 month after randomization
Postoperative complications
All postoperative complications will be recorded and compared between the two groups
Time frame: Up to 1 month after randomization
Postoperative pain
Postop pain will be assessed using the Pain Numeric Rating Scale (NRS-11) where patients will report their pain on a 0-10 scale, where higher scores mean worse pain. Overall scores will be compared between the two groups.
Time frame: Postop day 1, 2, 3, and 4
Opioid used in morphine milligram equivalents
Total postoperative opioid use will be recorded after converted into morphine milligram equivalents (MMEs) and compared between the two groups.
Time frame: Postop day 1, 2, 3, and 4
Plan to share: No
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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Neostigmine · Glycopyrrolate · Sugammadex
Clayton Petro