Intravenous Oliceridine and Opioid-related Complications

NCT04979247 | Completed Phase 4 FDA Drug

• 1 other identifier: 21-684
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 3

Brief Summary

The investigator will evaluate the side effects of oliceridine.

Conditions

Major Surgery

Outcome Measures

Primary Outcomes (1)

• Number of patients who have respiratory compromise.

  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.

  24 hours post first study dose.

Secondary Outcomes (2)

• Cumulative duration of oxygen saturation < 90%

  48 hours post first study dose.

• Cumulative duration of respiratory rate < 8 breaths/ minute

  48 hours post first study dose.

Study Arms (1)

Oliceridine

EXPERIMENTAL

Patients receive Oliceridine for pain control.

Drug: Oliceridine

Interventions

Oliceridine DRUG

Near the end of surgery, patients will be given ≤1.5 mg of oliceridine as a bolus. Postoperatively, patient-controlled analgesia (PCA) will be started with no background infusion, demand doses of 0.35 mg, with a 6 minute lock-out. Additional boluses (≤1 mg) of oliceridine will be given as deemed necessary (based on NRS score and clinical assessment of the patient) as soon as 15 minutes after the initial 1.5 mg loading dose. In addition to supplemental 1 mg bolus doses, the PCA demand dose can be increased to a maximum of 0.5 mg oliceridine.

Oliceridine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (3)

Wake Forest Bapist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Sessler DI, Ayad S, Bakal O, Disher NS, Duran JA, Weingarten TN, Dahan A, Demitrack MA, Kim J, Khanna AK; VOLITION Study Team. Oliceridine for postoperative pain and opioid-related complications: The intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study. J Clin Anesth. 2025 Jul;105:111870. doi: 10.1016/j.jclinane.2025.111870. Epub 2025 May 29.

  PMID: 40446423 DERIVED

MeSH Terms

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine

Study Officials

• Daniel I Sessler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 28, 2021
• Study Start: September 15, 2021
• Primary Completion: December 21, 2023
• Study Completion: January 10, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

US (3)