Clinical trial NCT04979247: Intravenous Oliceridine and Opioid-related Complications
Official title: Intravenous Oliceridine and Opioid-related Complications: VOLITION: A Multicenter Pilot Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Major Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigator will evaluate the side effects of oliceridine.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who have respiratory compromise.
timeFrame: 24 hours post first study dose.
Secondary outcomes:
measure: Cumulative duration of oxygen saturation < 90%
timeFrame: 48 hours post first study dose.
measure: Cumulative duration of respiratory rate < 8 breaths/ minute
timeFrame: 48 hours post first study dose.
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Bapist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References: