Constipation, Constipation Drug Induced
Conditions
Keywords
opioid-induced constipation (OIC)
Brief summary
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
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.
Interventions
DRUGNaloxegol 25 MG
Naloxegol 25 mg administered 1 hour pre-operatively
OTHERPlacebo pill
Placebo pill administered 1 hour pre-operatively
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to substantial bowel movement | Post-operative day 1 | Time to bowel movement of Type 2 or higher on the Bristol stool chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue medications | Post-operative day 1 | Amount of rescue medications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | Post-operative day 1 | CVICU length of stay |
Countries
United States
Contacts
Primary ContactJocelyn LaMar, BS
Backup ContactJennifer Perkins
Outcome results
None listed