Intravenous Oliceridine and Opioid-related Complications

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

The investigator will evaluate the side effects of oliceridine.

Study Overview

• Status: Recruiting
• Conditions: Major Surgery
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Roberta Johnson; Phone Number: 216-444-9950; Email: johnsor13@ccf.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Bapist Medical Center
      • Contact: Lynnette Harris; Email: lcharris@wakehealth.edu
      • Contact: Ashish K Khanna, MD; Phone Number: 336-716-4498; Email: akhanna@wakehealth.edu
      • Principal Investigator: Ashish K Khanna, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Main Campus
      • Principal Investigator: Daniel Sessler, MD
      • Contact: Roberta Johnson; Phone Number: 216-444-9950; Email: johnsor13@ccf.org
    • Cleveland, Ohio, United States, 44111
      • Recruiting
      • Cleveland Clinic Fairview Hospital
      • Contact: Eitan Nemirovsky Scher, MD; Phone Number: 216-476-0318; Email: scherne@ccf.org
      • Contact: Roberta Johnson; Phone Number: 216-444-9950; Email: johnsor13@ccf.org
      • Principal Investigator: Sabry Ayad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oliceridine; Patients receive Oliceridine for pain control.

Drug: Oliceridine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who have respiratory compromise.	Respiratory compromise will be defined by a collapsed (one or more) composite of 1) end-tidal carbon dioxide <15mmHg for ≥3 minutes; 2) respiratory rate ≤5 breaths/minute for ≥3 minutes; 3) SpO2 ≤ 85% for ≥3 minutes; 4) Apnea episode lasting >30 seconds; 5)any serious respiratory event.	24 hours post first study dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative duration of oxygen saturation < 90%	The sum of minutes with SpO2<90% from monitoring data	48 hours post first study dose.
Cumulative duration of respiratory rate < 8 breaths/ minute	The sum of minutes with respiratory rate < 8 from monitoring data	48 hours post first study dose.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Daniel I Sessler, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VOLITION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No