The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

NCT05985343 | Completed Phase 4 FDA Drug

• 1 other identifier: 23-700
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hernia, Ventral; Ileus

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Up to 1 month after randomization

• Postoperative complications

  Up to 1 month after randomization

• Postoperative pain

  Postop day 1, 2, 3, and 4

• Opioid used in morphine milligram equivalents

  Postop day 1, 2, 3, and 4

Study Arms (2)

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

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

Drug: Sugammadex

Interventions

Neostigmine / Glycopyrrolate DRUG

Patients will receive standard of care for reversal of neuromuscular blockade

Also known as: Control arm

Neostigmine/Glycopyrrolate

Sugammadex DRUG

Patients will receive sugammadex for reversal of neuromuscular blockade

Also known as: Experimental arm

Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Clayton Petro: lead

Study Sites (1)

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Ileus

Interventions

Neostigmine; Glycopyrrolate; Sugammadex

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Clayton C Petro, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded as to what medication they receive for reversal of neuromuscular blockade
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery Lerner College of Medicine

Model Details: Patients will be assigned to receive sugammadex or neostigmine/glycopyrrolate for reversal of neuromuscular blockade

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 14, 2023
• Study Start: January 15, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 2, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)