Intravenous Oliceridine and Opioid-related Complications
Completed · Phase 4
Conditions studied: Major Surgery
In brief
The investigator will evaluate the side effects of oliceridine.
Key facts
- Study ID
- NCT04979247
- Run by
- The Cleveland Clinic
- People needed
- 204
- Starts
- 2021-09-15
- Expected to finish
- 2024-01-10
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥18 years old
- American Society of Anesthesiologists physical status 1-4
- Scheduled for major noncardiac surgery expected to last at least 2 hours
- Expected to remain hospitalized at least two postoperative nights
- Scheduled for general endotracheal, spinal anesthesia, or the combination
- Expected to require substantial opioid analgesia, defined as ≥20 mg morphine equivalents
- Expected to have patient-controlled intravenous analgesia.
You may not qualify if…
- Are demented or otherwise cannot provide valid consent
- Have contraindications to oliceridine
- Used legal or illegal opioids chronically, defined as >15 mg morphine equivalents for >15 days during the month before consenting by history
- Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring
- Have planned epidural anesthesia/analgesia
- Planned spinal morphine administration
- Are designated Do Not Resuscitate, hospice, or receiving end of life therapy
- Are expected to require postoperative mechanical ventilation or ICU admission
- Are expected to receive intrathecal opioids
- Are expected to receive gabapentin, pregabalin or other analgesic adjuvants
- Use oxygen at home
- Are unwilling or unable to comply fully with study procedures (including not tolerating the capnography cannula)
- Are known to be pregnant or breastfeeding
- Use CPAP at home
- Have previously participated in the trial
Where it is running
- Wake Forest Bapist Medical Center — Winston-Salem, North Carolina, United States
- Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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