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Opioid Analgesic
Oliceridine for Major Surgery
Phase 4
Recruiting
Led By Daniel I Sessler, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
American Society of Anesthesiologists physical status 1-4
Expected to require substantial opioid analgesia, defined as ≥20 mg morphine equivalents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours post first study dose.
Awards & highlights
Study Summary
This trial will evaluate the side effects of the medication oliceridine.
Who is the study for?
This trial is for adults over 18 who are in stable physical condition and scheduled for major noncardiac surgery that requires a hospital stay. They should need significant pain relief post-surgery but can't be chronic opioid users, have certain health conditions, or be unable to consent.Check my eligibility
What is being tested?
The study is testing the side effects of Oliceridine, an intravenous medication given to manage pain after major surgeries. It's focused on how well it works and what adverse reactions patients might experience.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of opioids like Oliceridine may include nausea, vomiting, constipation, drowsiness, dizziness, itching or sweating. More serious risks could involve respiratory depression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good enough for surgery, but I may have serious health problems.
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I need strong pain medication equivalent to 20 mg of morphine or more.
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I am scheduled for surgery with general or spinal anesthesia.
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I will stay in the hospital for at least two nights after surgery.
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I am scheduled for a major surgery that is not heart-related and will last at least 2 hours.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours post first study dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours post first study dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who have respiratory compromise.
Secondary outcome measures
Cumulative duration of oxygen saturation < 90%
Cumulative duration of respiratory rate < 8 breaths/ minute
Side effects data
From 2017 Phase 3 trial • 418 Patients • NCT0281570956%
Nausea
39%
Vomiting
32%
Dizziness
25%
Headache
19%
Somnolence
15%
Pruritus
11%
Constipation
5%
Hypoxia
5%
Hyperhydrosis
5%
Sedation
5%
Dry Mouth
5%
Anxiety
4%
Oxygen Saturation Decreased
4%
Hot Flush
4%
Pruritus Generalized
1%
Chest Discomfort
1%
Muscle Twitching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment 2 Oliceridine
Treatment 3 Oliceridine
Placebo
Treatment 1 Oliceridine
Morphine
Trial Design
1Treatment groups
Experimental Treatment
Group I: OliceridineExperimental Treatment1 Intervention
Patients receive Oliceridine for pain control.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oliceridine
2023
Completed Phase 4
~860
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,036 Previous Clinical Trials
1,368,793 Total Patients Enrolled
1 Trials studying Major Surgery
6,254 Patients Enrolled for Major Surgery
Daniel I Sessler, MDPrincipal InvestigatorThe Cleveland Clinic
33 Previous Clinical Trials
97,088 Total Patients Enrolled
1 Trials studying Major Surgery
6,254 Patients Enrolled for Major Surgery
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I use oxygen at home.I cannot take oliceridine due to health reasons.I have been using opioids regularly for the past month.My health is good enough for surgery, but I may have serious health problems.I need strong pain medication equivalent to 20 mg of morphine or more.I am scheduled for surgery with general or spinal anesthesia.I am expected to take pain relief medication like gabapentin or pregabalin.I will stay in the hospital for at least two nights after surgery.I am able to understand and give consent for my treatment.I am scheduled for a major surgery that is not heart-related and will last at least 2 hours.I am scheduled to receive spinal morphine.I am 18 years old or older.I am scheduled for epidural anesthesia.I am expected to receive pain medication directly into my spinal canal.I use a CPAP machine at home for my sleep apnea.I will manage my pain using a patient-controlled IV pain relief system.I am not under hospice care or receiving end-of-life therapy.I will likely need help breathing or intensive care after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Oliceridine
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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