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New Painkiller's breathing risks scrutinized in 204-Patient trial

NCT ID NCT04979247

Knowledge-focused Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study involved 204 adults having major surgery to see what side effects oliceridine, a pain medicine, might cause. Researchers focused on breathing problems like low oxygen levels. The goal was to better understand the drug's safety, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

204 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major surgery

Contacts and locations

Locations

  • Cleveland Clinic Fairview Hospital

    Cleveland, Ohio, 44111, United States

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195, United States

  • Wake Forest Bapist Medical Center

    Winston-Salem, North Carolina, 27157, United States

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