Naloxegol and Opioid-induced Constipation
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- STATUS
- Recruiting
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- End date
- Dec 1, 2022
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- participants needed
- 280
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- sponsor
- TriHealth Inc.
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.
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.
Details
| Condition | Constipation, Constipation Drug Induced |
|---|---|
| Treatment | Naloxegol 25 MG, Placebo Pill |
| Clinical Study Identifier | NCT03316859 |
| Sponsor | TriHealth Inc. |
| Last Modified on | 10 May 2022 |
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