COMPLETED

Intravenous Oliceridine and Opioid-related Complications

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Conditions

Major Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigator will evaluate the side effects of oliceridine.

Official Title

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

Quick Facts

Study Start:2021-09-15
Study Completion:2024-01-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04979247

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old
  2. * American Society of Anesthesiologists physical status 1-4
  3. * Scheduled for major noncardiac surgery expected to last at least 2 hours
  4. * Expected to remain hospitalized at least two postoperative nights
  5. * Scheduled for general endotracheal, spinal anesthesia, or the combination
  6. * Expected to require substantial opioid analgesia, defined as ≥20 mg morphine equivalents
  7. * Expected to have patient-controlled intravenous analgesia.
  1. * Are demented or otherwise cannot provide valid consent
  2. * Have contraindications to oliceridine
  3. * Used legal or illegal opioids chronically, defined as \>15 mg morphine equivalents for \>15 days during the month before consenting by history
  4. * Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring
  5. * Have planned epidural anesthesia/analgesia
  6. * Planned spinal morphine administration
  7. * Are designated Do Not Resuscitate, hospice, or receiving end of life therapy
  8. * Are expected to require postoperative mechanical ventilation or ICU admission
  9. * Are expected to receive intrathecal opioids
  10. * Are expected to receive gabapentin, pregabalin or other analgesic adjuvants
  11. * Use oxygen at home
  12. * Are unwilling or unable to comply fully with study procedures (including not tolerating the capnography cannula)
  13. * Are known to be pregnant or breastfeeding
  14. * Use CPAP at home
  15. * Have previously participated in the trial

Contacts and Locations

Principal Investigator

Daniel I Sessler, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Wake Forest Bapist Medical Center
Winston-Salem, North Carolina, 27157
United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Daniel I Sessler, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-15
Study Completion Date2024-01-10

Study Record Updates

Study Start Date2021-09-15
Study Completion Date2024-01-10

Terms related to this study

Additional Relevant MeSH Terms

  • Major Surgery