Major SurgeryPhase 4NCT04979247
Intravenous Oliceridine and Opioid-related Complications
A Phase 4 study testing Oliceridine in people with Major Surgery, run by The Cleveland Clinic at 3 sites in United States.
Trial summary
The investigator will evaluate the side effects of oliceridine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Surgery
- What is being tested?
- Oliceridine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2021to 10 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Wake Forest Bapist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Intravenous Oliceridine and Opioid-related Complications: VOLITION: A Multicenter Pilot Cohort Study
The investigator will evaluate the side effects of oliceridine.
Read the 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.
- Conditions
- Major Surgery
- Being tested
- Oliceridine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine | Experimental | Patients receive Oliceridine for pain control. Receives: Drug: Oliceridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Meaningful Respiratory Compromise Events
Occurrence of clinically meaningful respiratory compromise events i.e. SpO2 ≤ 85 % for ≥3 min, etPCO2 ≤ 15 mmHg; ≥ 3 min, RR ≤ 5 bpm for ≥3 min, Apnea Event >30 s
Measured: 48 hours post first study dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Sep 2021
- Primary completion21 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979247
- Sponsor's protocol ID
- 21-684
- Status last verified
- Feb 2026
- First submitted
- 16 Jul 2021
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sessler DI, Ayad S, Bakal O, Disher NS, Duran JA, Weingarten TN, Dahan A, Demitrack MA, Kim J, Khanna AK; VOLITION Study Team. Oliceridine for postoperative pain and opioid-related complications: The intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study. J Clin Anesth. 2025 Jul;105:111870. doi: 10.1016/j.jclinane.2025.111870. Epub 2025 May 29.
PubMed 40446423
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Oliceridine and Opioid-related Complications: VOLITION: A Multicenter Pilot Cohort Study
- ClinicalTrials.gov ID
- NCT04979247
- Acronym / sponsor ID
- 21-684
- Conditions
- Major Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oliceridine | Experimental | Drug: OliceridinePatients receive Oliceridine for pain control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OliceridineNear 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. | Drug | Oliceridine |
Primary outcome
Clinically Meaningful Respiratory Compromise Events
Time frame: 48 hours post first study dose.
Occurrence of clinically meaningful respiratory compromise events i.e. SpO2 ≤ 85 % for ≥3 min, etPCO2 ≤ 15 mmHg; ≥ 3 min, RR ≤ 5 bpm for ≥3 min, Apnea Event >30 s
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40446423Sessler DI, Ayad S, Bakal O, Disher NS, Duran JA, Weingarten TN, Dahan A, Demitrack MA, Kim J, Khanna AK; VOLITION Study Team. Oliceridine for postoperative pain and opioid-related complications: The intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study. J Clin Anesth. 2025 Jul;105:111870. doi: 10.1016/j.jclinane.2025.111870. Epub 2025 May 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I Sessler, MD principal investigator
The Cleveland Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oliceridine in people with Major Surgery, run by The Cleveland Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Meaningful Respiratory Compromise Events (time frame: 48 hours post first study dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04979247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.