The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

Ileus Clinical Trial

Official title:

The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985343
• Other study ID #: 23-700
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: The Cleveland Clinic
• Contact: Clayton C Petro, MD
• Phone: 216 445-0053
• Email: petroc[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Ventral
• Ileus

Intervention

Drug:
• Neostigmine / Glycopyrrolate
Patients will receive standard of care for reversal of neuromuscular blockade
• Sugammadex
Patients will receive sugammadex for reversal of neuromuscular blockade

Locations

Country	Name	City	State
United States	Cleveland Clinic Center for Abdominal Core Health	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Clayton Petro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of stay	Duration of hospital stay as measured in hours from end of surgery to placement of discharge order will be	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
Secondary	Postoperative nasogastric tube placement rate	Placement of nasogastric tube for nausea/vomiting after surgery will be recorded and compared between the two groups.	Up to 1 month after randomization
Secondary	Postoperative complications	All postoperative complications will be recorded and compared between the two groups	Up to 1 month after randomization
Secondary	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.	Postop day 1, 2, 3, and 4
Secondary	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.	Postop day 1, 2, 3, and 4