Naloxegol and Opioid-induced Constipation

Study Overview
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Brief Summary
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This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.

Detailed Description
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This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.

Official Title
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A Prospective Randomized, Double-Blind Study to Evaluate the Addition of Naloxegol to the Pre-Op Regimen of the Cardiac Surgery Patient and Its Effect on Opioid-Induced Constipation

Conditions
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Constipation, Constipation Drug Induced

Intervention / Treatment
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* Drug: Naloxegol 25 MG
* Other: Placebo pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital Admitted to Bethesda North TriHealth Hospital CVICU post-surgery Exclusion Criteria: Medically unstable Cognitive deficits that impair the patient's ability to understand the informed consent Language barriers Patient has a documented diagnosis of one of the following: Crohn's disease; Ulcerative Colitis; History of bowel surgery that will impact absorption of study drug (as deemed by physician); History of small bowel obstruction Chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: Linzess, Trulance, Amitza, Senna/Senokot, Colace, Dulcolax, Miralax, Metamucil Patients on following medications prior to time of consent: Diltiazem, Verapamil, Amiodarone, Ketoconazole, Clarithromycin/ erythromycin, Antivirals Conditions that present an increased risk of bowel perforation (as determined by the physician) Pre-existing diagnosis of opioid-induced constipation AND receiving naloxegol as a treatment by their physician

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naloxegol<br>naloxegol 25 mg pill | Drug: Naloxegol 25 MG<br>* Naloxegol 25 mg administered 1 hour pre-operatively<br>* Other names: Movantik;|
| Placebo Comparator: Placebo<br>placebo pill | Other: Placebo pill<br>* Placebo pill administered 1 hour pre-operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to substantial bowel movement | Time to bowel movement of Type 2 or higher on the Bristol stool chart | Post-operative day 1 | 
| Time to substantial bowel movement | Time to bowel movement of Type 2 or higher on the Bristol stool chart | Post-operative day 2 | 
| Time to substantial bowel movement | Time to bowel movement of Type 2 or higher on the Bristol stool chart | Post-operative day 3 | 
| Time to substantial bowel movement | Time to bowel movement of Type 2 or higher on the Bristol stool chart | Post-operative day 4 | 
| Time to substantial bowel movement | Time to bowel movement of Type 2 or higher on the Bristol stool chart | Post-operative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue medications | Amount of rescue medications | Post-operative day 1 | 
| Rescue medications | Amount of rescue medications | Post-operative day 2 | 
| Rescue medications | Amount of rescue medications | Post-operative day 3 | 
| Rescue medications | Amount of rescue medications | Post-operative day 4 | 
| Rescue medications | Amount of rescue medications | Post-operative day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid-induced constipation (OIC)