Oliceridine for Major Surgery

Recruiting in Cleveland (>99 mi)

+2 other locations

Overseen By Roberta Johnson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

Must not be taking: Gabapentin, Pregabalin, others

Disqualifiers: Dementia, Chronic opioid use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigator will evaluate the side effects of oliceridine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are expected to receive certain pain medications like gabapentin or pregabalin.

What safety data exists for Oliceridine (Olinvyk) in humans?

The provided research articles do not contain specific safety data for Oliceridine (Olinvyk). ^{1 2 3 4 5}

Research Team

Daniel Sessler, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

Are known to be pregnant or breastfeeding

Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring

I use oxygen at home.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Oliceridine for pain control and are monitored for respiratory compromise

48 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Oliceridine

Trial Overview 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.

Participant Groups

Group I: Oliceridine Experimental Treatment 1 Intervention

Patients receive Oliceridine for pain control.

Oliceridine is already approved in United States for the following indications:

Approved in United States as Olinvyk for:

• Management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

A large analysis of adverse event reports revealed that tofacitinib/XR had significantly higher rates of cardiovascular-related (14.1%) and blood clot-related (14.8%) events compared to baricitinib and upadacitinib, indicating potential safety concerns for this medication.

Baricitinib was associated with the highest proportions of death (7.2%) and cancer-related (4.1%) adverse events, suggesting that while all three drugs are in the same class, their safety profiles may differ significantly, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of adverse event reporting of Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to the US Food and Drug Administration. Qian, J., Xue, X., Shannon, J.[2023]

Sugammadex is associated with fewer cases of bradycardia compared to neostigmine in pediatric patients, indicating a potentially safer profile for reversing neuromuscular blockade.

The use of sugammadex resulted in significantly shorter recovery times from anesthesia, especially in neonates, suggesting it is more effective than neostigmine for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children. Gaver, RS., Brenn, BR., Gartley, A., et al.[2020]

OpenVigil FDA is a new web-based tool that simplifies access to pharmacovigilance data, allowing healthcare professionals to analyze drug safety and adverse events without needing special licenses or complex statistical software.

The tool enables users to perform various analyses, such as identifying drugs linked to adverse events and comparing safety profiles, making it a practical resource for clinicians to address real-life clinical issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications. Böhm, R., von Hehn, L., Herdegen, T., et al.[2022]

A study analyzing 4,339 adverse events (AEs) associated with radium-223 from the Eudra-Vigilance database found that the most common AEs were hematological, general, and gastrointestinal disorders, with over 90% classified as serious and 8% fatal.

Older patients (over 85 years) treated with radium-223 showed a higher risk of cardiac, infectious, and metabolic disorders compared to younger patients, indicating the need for careful monitoring in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. Tema, G., Lombardo, R., Voglino, O., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Characteristics of adverse event reporting of Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to the US Food and Drug Administration. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. [2021]