Evaluating the side effects of oliceridine in major surgery patients

Intravenous Oliceridine and Opioid-related Complications: VOLITION: A Multicenter Pilot Cohort Study

This study is testing whether oliceridine, a pain medication, causes fewer breathing problems than regular opioids in patients having major surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 3 sites (Winston-Salem, North Carolina and 2 other locations)
• Trial ID: NCT04979247 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for major noncardiac surgery requiring substantial opioid analgesia.

Not a fit: Patients with contraindications to oliceridine or those who have chronic opioid use may not benefit from this study.

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 performed: Limited information suggests that oliceridine may be more effective with fewer side effects than traditional opioids, indicating potential success in similar studies.

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

Where this trial is running

Winston-Salem, North Carolina and 2 other locations

• 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

Conditions: Major Surgery