Clinical trial NCT05985343: The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction
Official title: The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hernia, Ventral
Ileus
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to receive sugammadex or neostigmine/glycopyrrolate for reversal of neuromuscular blockade
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to GI-2 bowel function after surgery
timeFrame: 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:
measure: Length of stay
timeFrame: 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
measure: Postoperative nasogastric tube placement rate
timeFrame: Up to 1 month after randomization
measure: Postoperative complications
timeFrame: Up to 1 month after randomization
measure: Postoperative pain
timeFrame: Postop day 1, 2, 3, and 4
measure: Opioid used in morphine milligram equivalents
timeFrame: Postop day 1, 2, 3, and 4
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Abdominal Core Health
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Clayton C Petro, MD
role: PRINCIPAL_INVESTIGATOR
References: