Intravenous Oliceridine and Opioid-related Complications

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Major Surgery

Treatments: Drug: Oliceridine

Study type: Interventional

Funder types: Other

Identifiers

NCT04979247

21-684

Details and patient eligibility

About

The investigator will evaluate the side effects of oliceridine.

Full description

The investigator will evaluate the side effects of oliceridine. Limited information suggests that oliceridine may cause fewer side effects than the standard opioids given post surgery. Oliceridine is effective for treating acute pain, and is approved by the FDA. Patients will wear a device that continuously monitors breathing. Data from this monitor will be blinded to the clinical staff. Primary Aims include: The investigators will evaluate the proportion of patients having an adjudicated meaningful respiratory compromise with a specified precision of 0.15 using a 95% confidence interval at 24 hours post first study dose.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

Oliceridine

Experimental group

Description:

Patients receive Oliceridine for pain control.

Treatment:

Drug: Oliceridine