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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine / Glycopyrrolate | Drug | Patients will receive standard of care for reversal of neuromuscular blockade |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Postoperative nasogastric tube placement rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clayton C Petro, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Center for Abdominal Core Health | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D045823 | Ileus |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Patients will be assigned to receive sugammadex or neostigmine/glycopyrrolate for reversal of neuromuscular blockade
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The patient will be blinded as to what medication they receive for reversal of neuromuscular blockade
| Sugammadex | Drug | Patients will receive sugammadex for reversal of neuromuscular blockade |
|
|
Placement of nasogastric tube for nausea/vomiting after surgery will be recorded and compared between the two groups. |
| Up to 1 month after randomization |
| Postoperative complications | All postoperative complications will be recorded and compared between the two groups | 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. | 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. | Postop day 1, 2, 3, and 4 |
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009861 |
| Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |