Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Study Overview
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Brief Summary
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The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery

Detailed Description
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Neuromuscular blocking agents are essential during surgical procedures to paralyze the body to avoid unnecessary movement during surgery. There are various medications, such as Sugammadex that are later used to reverse the effects of the neuromuscular blockade. The U.S. performs approximately 320,000 colectomies per year for benign and malignant conditions such as Ulcerative Colitis (UC). Bowel resection surgery removes a portion of small or large intestine. Currently, there is little available prospective outcomes data regarding the use of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (hour) to first bowel movement and tolerance for solid food (aka GI-2 recovery) following bowel resection surgery. The study team will be conducting a randomized triple-blind study (patient's assigned group is hidden from the patient, provider, and research team). Randomization is created by using an electronic randomizer. Upon consent, the patient's assignment (per the randomizer) will be submitted to the Investigational Drug Service (IDS) Pharmacy by a department employee with no direct patient interaction.

Official Title
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Sugammadex Reversal VS Neostigmine and Glycopyrrolate Competitive Antagonism of Neuromuscular Blockade for GI-2 Recovery After Bowel Resection: Prospective, Randomized, Triple-blinded Clinical Trial for Quality Improvement

Conditions
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Intestinal Disease

Intervention / Treatment
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* Drug: Neostigmine Injectable Solution
* Drug: Sugammadex injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission Exclusion Criteria: Allergy to Rocuronium, Vecuronium, or Sugammadex Bowel resection surgery requiring an ostomy No severe valvulopathy, no systolic heart failure with reduced ejection fraction (HFrEF), no coronary artery disease with positive stress test for ischemic regional wall motion abnormality No autoimmune pulmonary disease, no severe pulmonary fibrosis, no severe pulmonary hypertension, no COPD with requirement of home oxygen, no pulmonary cancer of primary or metastatic origin Creatinine Clearance (CrCl) of less than 30 Pregnancy Incapable of providing consent or understanding the research project

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine plus Glycopyrrolate<br>0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate 2 syringes numbered 1 and 2 Syringe #1: Glycopyrrolate Syringe #2: Neostigmine | Drug: Neostigmine Injectable Solution<br>* Examine GI-2 recovery<br>* Other names: Group B;|
| Active Comparator: Sugammadex<br>2.0 mg/kg of Sugammadex plus saline equivalent 2 syringes numbered 1 and 2 Syringe #1: 0.9% sodium chloride Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume) | Drug: Sugammadex injection<br>* Examine GI-2 recovery<br>* Other names: Group A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI-2 Recovery | GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet | Up to 24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of Stay | Total cost of surgical stay | From hospital admission to discharge, up to 30 days | 
| Length of Stay | Total time patient is at hospital | From hospital admission to discharge, up to 60 days | 
| Morbidity & Mortality Rate | Symptomatic disease presence and death | 30 days post surgery | 
| Number of Participants Experiencing Post Reversal Bradycardia | Slowed heart rate following reversal | Post surgically but prior to PACU discharge, up to 24 hours | 
| Duration of PACU Stay | Time in PACU, not owing to bed availability | From surgical end time to PACU discharge, up to 24 hours | 
| Time to Out of Bed | Time for patient to be able to get out of bed and walk post surgically | Up to 24 hours post surgery | 
| Amount of Fluid Administration | IV fluid administration during surgery | Intraoperative | 
| Presence of Bowel Adhesion | Scar tissue found in bowels | Intraoperative | 
| Number of Participants Experiencing PONV | Post operative nausea and vomiting | Postoperative to discharge, up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Bowel Resection, Sugammadex, Neostigmine, Glycopyrrolate, GI-2