Naloxegol and Opioid-induced Constipation

TriHealth Inc.280 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

280

Conditions

Constipation Constipation Drug Induced

Interventions

Naloxegol 25 MGDRUG

Naloxegol 25 mg administered 1 hour pre-operatively

Placebo pillOTHER

Placebo pill administered 1 hour pre-operatively

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bethesda North TriHealth Hospital

Cincinnati, Ohio, United States

RECRUITING