Evaluating the side effects of oliceridine in major surgery patients
Official title: Intravenous Oliceridine and Opioid-related Complications: VOLITION: A Multicenter Pilot Cohort Study
Run by The Cleveland Clinic · NCT04979247 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether oliceridine, a pain medication, causes fewer breathing problems than regular opioids in patients having major surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 3 sites (Winston-Salem, North Carolina and 2 other locations) |
| Trial ID | NCT04979247 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults scheduled for major noncardiac surgery requiring substantial opioid analgesia.
✕Probably not a fit
Patients with contraindications to oliceridine or those who have chronic opioid use may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the side effects of oliceridine, a medication approved for treating acute pain, in patients undergoing major noncardiac surgery. The research aims to determine if oliceridine causes fewer side effects compared to standard opioids. Patients will be monitored for respiratory compromise using a device that continuously tracks their breathing, with data kept blinded from clinical staff. The primary goal is to assess the proportion of patients experiencing significant respiratory issues within 24 hours after the first dose.
Why it matters
Potential benefit: If successful, this study could lead to safer pain management options for patients undergoing major surgery.
How similar studies have gone: Limited information suggests that oliceridine may be more effective with fewer side effects than traditional opioids, indicating potential success in similar studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Wake Forest Bapist Medical Center
Winston-Salem, North Carolina, United States Recruiting -
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States Recruiting -
Cleveland Clinic Main Campus
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Daniel I Sessler, MD — The Cleveland Clinic
- Study coordinator: Roberta Johnson
- Email: johnsor13@ccf.org
- Phone: 216-444-9950
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Landiolol to prevent fast heart rates during major non-cardiac surgery in patients with cardiovascular risk
This will test whether giving the ultra‑short acting beta‑blocker landiolol to people over 45 with cardiovascular risk factors who are having major non‑cardiac surgery can keep heart rate below 90 bpm throughout the perioperative period and reduce heart injury.
-
Comparing ketamine delivery methods for postoperative pain management in orthopedic surgery
This study is testing whether giving ketamine through an IV or a patient-controlled pump works better for managing pain after major orthopedic surgery in adults.
-
Evaluating the impact of standardized handover in major surgery
This study is testing if a new way for anesthetists to share important patient information during major surgery can help reduce serious problems after surgery and improve patient satisfaction.
-
Prehabilitation program for elderly patients undergoing major surgery
This study tests if a special program that includes exercise, better nutrition, and other health improvements can help older patients recover better after major surgery compared to standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.