Intravenous Oliceridine and Opioid-related Complications

• Status: Recruiting
• Trial end date: 2025-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The investigator will evaluate the side effects of oliceridine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic

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