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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naloxegol | Experimental | naloxegol 25 mg pill |
|
| Placebo | Placebo Comparator | placebo pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxegol 25 MG | Drug | Naloxegol 25 mg administered 1 hour pre-operatively |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue medications | Amount of rescue medications | Post-operative day 1 |
| Rescue medications | Amount of rescue medications | Post-operative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | CVICU length of stay | Post-operative day 1 |
| Length of stay | CVICU length of stay | Post-operative day 2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jocelyn LaMar, BS | Contact | 513-865-5072 | Jocelyn_LaMar@trihealth.com | |
| Jennifer Perkins | Contact | 513-865-1415 | jennifer_perkins@trihealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Scott McCardle, MD | Bethesda North TriHealth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bethesda North TriHealth Hospital | Recruiting | Cincinnati | Ohio | 45242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24896818 | Background | Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4. | |
| 25135384 | Background | DePriest AZ, Miller K. Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence. Pain Ther. 2014 Jun;3(1):1-15. doi: 10.1007/s40122-014-0026-2. Epub 2014 May 6. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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| Placebo pill | Other | Placebo pill administered 1 hour pre-operatively |
|
| 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 |
| Length of stay | CVICU length of stay | Post-operative day 3 |
| Length of stay | CVICU length of stay | Post-operative day 4 |
| Length of stay | CVICU length of stay | Post-operative day 5 |
| 26136838 | Background | Nelson AD, Camilleri M. Chronic opioid induced constipation in patients with nonmalignant pain: challenges and opportunities. Ther Adv Gastroenterol. 2015 Jul;8(4):206-20. doi: 10.1177/1756283X15578608. |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |