The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

Clayton Petro

Status and phase: Completed; Phase 4

Conditions: Ileus; Hernia, Ventral

Treatments: Drug: Sugammadex; Drug: Neostigmine / Glycopyrrolate

Study type: Interventional

Funder types: Other

Identifiers

NCT05985343

23-700

Details and patient eligibility

About

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).

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.
• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Neostigmine/Glycopyrrolate

Other group

Description:

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

Treatment:

Drug: Neostigmine / Glycopyrrolate

Sugammadex

Other group

Description:

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

Treatment:

Drug: Sugammadex