Intravenous Oliceridine and Opioid-related Complications

Major Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979247
• Other study ID #: VOLITION
• Status: Recruiting
• Phase: Phase 4
• Start date: September 15, 2021
• Est. completion date: July 15, 2025

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: Roberta Johnson
• Phone: 216-444-9950
• Email: johnsor13[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator will evaluate the side effects of oliceridine.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 15, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Major Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Main Campus	Cleveland	Ohio
United States	Wake Forest Bapist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative duration of oxygen saturation < 90%	The sum of minutes with SpO2<90% from monitoring data	48 hours post first study dose.
Secondary	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.