Hernia, VentralPhase 4NCT05985343
The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction
A Phase 4 study testing Neostigmine / Glycopyrrolate and Sugammadex in people with Hernia, Ventral and Ileus, run by Clayton Petro at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral, Ileus
- What is being tested?
- Neostigmine / Glycopyrrolate and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 2 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years old
- Patients requiring an open ventral hernia repair with retromuscular mesh placement and at least one myofascial advancement flap
- Hernias with fascial defects < 20cm wide
- Non-emergent cases
Who cannot join
- Known serious or severe hypersensitivity reaction to sugammadex or any of the ingredients in sugammadex.
- Hernias with fascial defects > 20cm wide
- Concomitant treatment with a strong or moderate cytochrome P450 3A4 inhibitor (e.g., Ketoconazole and other anti-fungals, Clarithromycin, HIV protease inhibitors, diltiazem, erythromycin, verapamil) or strong CYP3A4 inducers (e.g., rifampin).
- Known small bowel obstruction (SBO) at the time of hernia repair
- Suspected SBO or at risk of recurrent SBO at the time of hernia repair - at the discretion of the staff surgeon.
- Nasogastric (NG), orogastric (OG), or gastric (eg. PEG) in place at the time of hernia repair and left in beyond the morning of the first postoperative day.
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- Patients with a stoma.
- Cancer with increased risk of gastro-duodenal perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab) - at the discretion of the staff surgeon.
- Disorder that could alter the integrity of the gastrointestinal lining (e.g., Crohn's disease) - at the discretion of the staff surgeon.
- Severe hepatic failure (Child-Pugh Class C).
- Clinically relevant hepatic failure (e.g. cirrhosis) - at the discretion of the staff surgeon.
- Severe renal failure (GFR<30ml/min, on dialysis, or have an arteriovenous fistula, indwelling hemodialysis catheter or peritoneal dialysis catheter) - at the discretion of the staff surgeon.
- Pregnant or planning to become pregnant during study period.
- Breastfeeding or planning to breastfeed during study period.
- Clinically relevant alteration of the blood-brain-barrier - at the discretion of the staff surgeon.
- Other contraindication to sugammadex as documented by a physician.
- Unable to give informed consent; vulnerable populations; non-English speaking.
- Emergent operation.
- Undergoing minimally invasive approaches.
- Undergoing repair with mesh placed in a position other than retromuscular.
- Chronic opioid users, as defined by the daily use of opioids for at least 90 days within the past year
- Inability to safely extubate the patient at the end of the surgery for any reason, as determined by the operative team.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, 44195
About this study
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).
Read the detailed description
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:
- postoperative time to return of bowel function (GI-2) after open AWR will be significantly shorter for patients who receive sugammadex for reversal of neuromuscular blockade when compared to those receiving standard of care (neostigmine/glycopyrrolate).
- patients who receive sugammadex for reversal of neuromuscular blockade will have a reduced incidence of POI requiring nasogastric tube (NG) placement, and decreased length of hospital stay when compared to standard of care.
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.
- Conditions
- Hernia, Ventral, Ileus
- Being tested
- Neostigmine / Glycopyrrolate, Sugammadex
- Medical subject headings
- Hernia, Ventral, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine / GlycopyrrolateDrug
Also called Control arm
Patients will receive standard of care for reversal of neuromuscular blockade
SugammadexDrug
Also called Experimental arm
Patients will receive sugammadex for reversal of neuromuscular blockade
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine/Glycopyrrolate | Other | 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 Receives: Drug: Neostigmine / Glycopyrrolate |
| Sugammadex | Other | 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 Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (5)
Length of stay
Duration of hospital stay as measured in hours from end of surgery to placement of discharge order will be
Measured: 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.
Measured: Up to 1 month after randomization
Postoperative complications
All postoperative complications will be recorded and compared between the two groups
Measured: 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.
Measured: 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.
Measured: Postop day 1, 2, 3, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Jan 2024
- Primary completion30 May 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to receive sugammadex or neostigmine/glycopyrrolate for reversal of neuromuscular blockade
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clayton Petro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clayton Petro, The Cleveland Clinic
- Investigators
- Clayton C Petro, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985343
- Sponsor's protocol ID
- 23-700
- Status last verified
- Oct 2025
- First submitted
- 1 Aug 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction
- ClinicalTrials.gov ID
- NCT05985343
- Acronym / sponsor ID
- 23-700
- Conditions
- Hernia, Ventral, Ileus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Clayton PetroUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- postoperative time to return of bowel function (GI-2) after open AWR will be significantly shorter for patients who receive sugammadex for reversal of neuromuscular blockade when compared to those receiving standard of care (neostigmine/glycopyrrolate).
- patients who receive sugammadex for reversal of neuromuscular blockade will have a reduced incidence of POI requiring nasogastric tube (NG) placement, and decreased length of hospital stay when compared to standard of care.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be assigned to receive sugammadex or neostigmine/glycopyrrolate for reversal of neuromuscular blockade
| Arm | Type | Receives |
|---|---|---|
| Neostigmine/Glycopyrrolate | Other | Drug: Neostigmine / GlycopyrrolatePatients 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 |
| Sugammadex | Other | Drug: SugammadexPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults >18 years old
- Patients requiring an open ventral hernia repair with retromuscular mesh placement and at least one myofascial advancement flap
- Hernias with fascial defects < 20cm wide
- Non-emergent cases
Key exclusion criteria (22 listed)
- Known serious or severe hypersensitivity reaction to sugammadex or any of the ingredients in sugammadex.
- Hernias with fascial defects > 20cm wide
- Concomitant treatment with a strong or moderate cytochrome P450 3A4 inhibitor (e.g., Ketoconazole and other anti-fungals, Clarithromycin, HIV protease inhibitors, diltiazem, erythromycin, verapamil) or strong CYP3A4 inducers (e.g., rifampin).
- Known small bowel obstruction (SBO) at the time of hernia repair
- Suspected SBO or at risk of recurrent SBO at the time of hernia repair - at the discretion of the staff surgeon.
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 |
|---|---|---|
| Neostigmine / GlycopyrrolateAlso: Control armPatients will receive standard of care for reversal of neuromuscular blockade | Drug | Neostigmine/Glycopyrrolate |
| SugammadexAlso: Experimental armPatients will receive sugammadex for reversal of neuromuscular blockade | Drug | Sugammadex |
Primary outcome
Time to GI-2 bowel function after surgery
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
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.
5 secondary outcomes
Length of stay
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
Time frame: Up to 1 month after randomization
Postoperative complications
Time frame: Up to 1 month after randomization
Postoperative pain
Time frame: Postop day 1, 2, 3, and 4
Opioid used in morphine milligram equivalents
Time frame: Postop day 1, 2, 3, and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Clayton C Petro, MD principal investigator
The Cleveland Clinic
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 Neostigmine / Glycopyrrolate and Sugammadex in people with Hernia, Ventral and Ileus, run by Clayton Petro 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 22 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: finished, as of the sponsor's last update on 21 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to GI-2 bowel function after surgery (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). 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 21 Nov 2025.