Intravenous Oliceridine and Opioid-related Complications

Phase 4

Recruiting

• Conditions: Major Surgery
• Interventions: Drug: Oliceridine

• Registration Number: NCT04979247
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The investigator will evaluate the side effects of oliceridine.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Study Start: 2021-09-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oliceridine	Oliceridine	Patients receive Oliceridine for pain control.

Primary Outcome Measures

Name	Time	Method
Number of patients who have respiratory compromise.	24 hours post first study dose.	Respiratory compromise will be defined by a collapsed (one or more) composite of 1) end-tidal carbon dioxide \<15mmHg for ≥3 minutes; 2) respiratory rate ≤5 breaths/minute for ≥3 minutes; 3) SpO2 ≤ 85% for ≥3 minutes; 4) Apnea episode lasting \>30 seconds; 5)any serious respiratory event.

Secondary Outcome Measures

Name	Time	Method
Cumulative duration of oxygen saturation < 90%	48 hours post first study dose.	The sum of minutes with SpO2\<90% from monitoring data
Cumulative duration of respiratory rate < 8 breaths/ minute	48 hours post first study dose.	The sum of minutes with respiratory rate \< 8 from monitoring data

Trial Locations

Locations (3)

Cleveland Clinic Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States

Wake Forest Bapist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States