Intravenous Oliceridine and Opioid-related Complications

Description

The investigator will evaluate the side effects of oliceridine.

Conditions

Major Surgery

Study Overview

Study Details

Study overview

The investigator will evaluate the side effects of oliceridine.

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

Intravenous Oliceridine and Opioid-related Complications

Condition
Major Surgery
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest Bapist Medical Center, Winston-Salem, North Carolina, United States, 27157

Cleveland

Cleveland Clinic Fairview Hospital, Cleveland, Ohio, United States, 44111

Cleveland

Cleveland Clinic Main Campus, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Daniel I Sessler, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-07-15