Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, 44195, United States
NCT Number: NCT05985343
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive standard of care for reversal of neuromuscular blockade
Other names: Control arm
Patients will receive sugammadex for reversal of neuromuscular blockade
Other names: Experimental arm
Time frame: 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
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.
Time frame: 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
Duration of hospital stay as measured in hours from end of surgery to placement of discharge order will be
Time frame: Up to 1 month after randomization
Placement of nasogastric tube for nausea/vomiting after surgery will be recorded and compared between the two groups.
Time frame: Up to 1 month after randomization
All postoperative complications will be recorded and compared between the two groups
Time frame: Postop day 1, 2, 3, and 4
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.
Time frame: Postop day 1, 2, 3, and 4
Total postoperative opioid use will be recorded after converted into morphine milligram equivalents (MMEs) and compared between the two groups.
Clayton Petro
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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