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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~48 hours post first study dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours post first study dose. for reporting.

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 • NCT02815709
56%
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
1,027 Previous Clinical Trials
1,364,078 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

Media Library

Oliceridine (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04979247 — Phase 4
Major Surgery Research Study Groups: Oliceridine
Major Surgery Clinical Trial 2023: Oliceridine Highlights & Side Effects. Trial Name: NCT04979247 — Phase 4
Oliceridine (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979247 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Oliceridine been the subject of any other scientific experiments?

"Oliceridine was initially trialled in 2021 at the Cleveland Clinic Fairview Hospital. 8 completed experiments have been documented, and there is currently one ongoing study based out of Winston-Salem, North carolina."

Answered by AI

Is enrollment still open for this clinical research trial?

"Affirmative. Data hosted on clinicaltrials.gov substantiates that this medical experiment is recruiting subjects in the present time. It was first uploaded to the website on September 15th 2021 and was last updated April 4th 2022, with 200 participants needed at 3 distinct locations."

Answered by AI

What safety measures have been taken to ensure Oliceridine's efficacy for patients?

"At Power, we gauged that Oliceridine has a safety rating of 3 as this is an FDA-approved Phase 4 trial."

Answered by AI

What is the cap on participants for this medical research?

"Correct. Clinicaltrials.gov reveals that this investigation, which was first initiated on September 15th 2021, is actively recruiting participants. 200 people need to be recruited from 3 different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intravenous Oliceridine and Opioid-related Complications
2021. "Intravenous Oliceridine and Opioid-related Complications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04979247.
~41 spots leftby Dec 2024
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