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The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

Primary Purpose

Hernia, Ventral, Ileus

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Neostigmine / Glycopyrrolate
Sugammadex
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hernia, Ventral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cleveland Clinic Center for Abdominal Core Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Neostigmine/Glycopyrrolate

Sugammadex

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of stay
Duration of hospital stay as measured in hours from end of surgery to placement of discharge order will be
Postoperative nasogastric tube placement rate
Placement of nasogastric tube for nausea/vomiting after surgery will be recorded and compared between the two groups.
Postoperative complications
All postoperative complications will be recorded and compared between the two groups
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.
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.

Full Information

First Posted
August 1, 2023
Last Updated
October 17, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05985343
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral, Ileus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to receive sugammadex or neostigmine/glycopyrrolate for reversal of neuromuscular blockade
Masking
Participant
Masking Description
The patient will be blinded as to what medication they receive for reversal of neuromuscular blockade
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neostigmine/Glycopyrrolate
Arm Type
Other
Arm 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
Arm Title
Sugammadex
Arm Type
Other
Arm 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
Intervention Type
Drug
Intervention Name(s)
Neostigmine / Glycopyrrolate
Other Intervention Name(s)
Control arm
Intervention Description
Patients will receive standard of care for reversal of neuromuscular blockade
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Experimental arm
Intervention Description
Patients will receive sugammadex for reversal of neuromuscular blockade
Primary Outcome Measure Information:
Title
Time to GI-2 bowel function after surgery
Description
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 of bowel function, which is an average of 87 hours, or until 1 month after randomization; whichever comes first
Secondary Outcome Measure Information:
Title
Length of stay
Description
Duration of hospital stay as measured in hours from end of surgery to placement of discharge order will be
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
Title
Postoperative nasogastric tube placement rate
Description
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
Title
Postoperative complications
Description
All postoperative complications will be recorded and compared between the two groups
Time Frame
Up to 1 month after randomization
Title
Postoperative pain
Description
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
Title
Opioid used in morphine milligram equivalents
Description
Total postoperative opioid use will be recorded after converted into morphine milligram equivalents (MMEs) and compared between the two groups.
Time Frame
Postop day 1, 2, 3, and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clayton C Petro, MD
Phone
216 445-0053
Email
petroc@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan C Ellis, MD
Phone
440 409-3948
Email
ellisr2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton C Petro, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Center for Abdominal Core Health
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton C Petro, MD
Phone
216-445-0053
Email
petroc@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

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The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

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