Phase 4
N=204
Intravenous Oliceridine and Opioid-related Complications
Major Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04979247 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Clinically Meaningful Respiratory Compromise Events — 45 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oliceridine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Meaningful Respiratory Compromise Events |
45 | — |
Summary
The investigator will evaluate the side effects of oliceridine.
Eligibility Criteria
Inclusion Criteria
- ≥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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04979247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.