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Completed

NCT Number: NCT04979247

Intravenous Oliceridine and Opioid-related Complications

The investigator will evaluate the side effects of oliceridine.

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Key information

Conditions

Major Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Clinically Meaningful Respiratory Compromise Events

    Time frame: 48 hours post first study dose.

    Occurrence of clinically meaningful respiratory compromise events i.e. SpO2 ≤ 85 % for ≥3 min, etPCO2 ≤ 15 mmHg; ≥ 3 min, RR ≤ 5 bpm for ≥3 min, Apnea Event >30 s

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 28, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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