Naloxegol and Opioid-induced Constipation

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.

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