1.Comparison of the Analgesic Effect of Remifentanil Group and Different Dose Groups of Oliceridine in Postoperative Patients Undergoing Cardiac Surgery 2.Exploring the Hemodynamic Effects of Analgesic Regimens With Different Doses of Oliceridine After Cardiac Surgery

September 27, 2024 updated by: Nanjing First Hospital, Nanjing Medical University

Oliceridine for Analgesia After Cardiac Surgery

Cardiac surgery has the characteristics of long duration and large amount of intraoperative bleeding, easy to involve multiple organs and severe tissue injury, which is one of the most serious surgical procedures with postoperative pain and the incidence of postoperative pain after open-heart surgery is as high as 50%, with the incidence of moderate-to-severe pain ranging from 3% to 18% . Currently, opioids are commonly used in clinical practice for postoperative cardiac analgesia, but due to the abnormal cardiac structure of cardiac surgery patients, surgery and extracorporeal circulation effects, hemodynamic fluctuations and respiratory depression, nausea and vomiting, dizziness, constipation, and other adverse reactions occur during analgesia [3]. Therefore, it is especially necessary to find an analgesic drug with good analgesic effect and able to reduce such adverse effects.

Oliceridine is a G-protein biased μ-opioid receptor agonist, which selectively activates the G-protein signaling pathway and significantly reduces the activation of the β-inhibitory protein pathway, preserving the analgesic effect while reducing the opioid-related adverse effects, and is currently used for intraoperative analgesia and analgesic treatment of acute moderate-to-severe pain occurring after surgery such as abdominal surgery and bunion bursitis, and is mostly administered by a single injection into the vein .A series of national and international clinical studies have been conducted on OliceridineA phase 1 clinical trial study conducted by Soergel et al. demonstrated that in healthy subjects, 3 and 4.5 mg ofOliceridine demonstrated higher peak analgesia (75 sec latency) compared to morphine. In addition, all doses were associated with lower respiratory drive reductions compared to morphine (- 7.3, - 7.6, and - 9.4 h*L/min vs - 15.9 h*L/min). Respiratory depression persisted with Oliceridine but was very transient, and subjects on the 1.5 mg and 3 mg doses experienced less nausea compared to subjects on the 4.5 mg dose and morphine. Overall, the 3 mg dose provided significant efficacy while still maintaining the reduction in PONV demonstrated by the low dose of choline.

To further investigate the effects of Oliceridine on the respiratory system, Simons et al. conducted a crossover study of 18 healthy elderly volunteers. The study found that while low doses of Oliceridine did not result in any significant respiratory effects, high doses of Oliceridine and two doses of morphine resulted in respiratory depression that peaked 0.5 to 1 hour after administration. However, similar to the earlier findings of Soergel et al, the respiratory depression induced by Oliceridine was more transient, characterized by a more rapid return to baseline, with an equilibrium half-life at the blood effector site of 44.3 ± 6.1 minutes compared with 214 ± 27 minutes for morphine.A subsequent phase III study was also conducted on the use of Oliceridine in the management of moderate to severe acute postoperative pain after abdominoplasty. The results showed that Oliceridine is a safe and effective intravenous analgesic for the relief of moderate to severe acute postoperative pain in patients undergoing abdominoplasty. Since the low-dose regimen of 0.1 mg of oseltamivirine was superior to placebo but not as effective as the morphine regimen, safety comparisons with morphine were only relevant to the 2 isoanalgesic dose groups of 0.35 and 0.5 mg, and oseltamivirine showed a favorable safety profile in terms of respiratory and gastrointestinal adverse effects tolerability compared with morphine. This suggests that Oliceridine may offer a new therapeutic option for patients with moderate to severe acute pain requiring intravenous opioids.Based on the relatively long duration of analgesia in postoperative cardiac surgery patients, there is a need to explore drugs with the advantages of better analgesic effect, less hemodynamic impact, sustained analgesia with fewer adverse effects, and rapid metabolism after discontinuation of the drug. Combining the existing research base of this project and the above domestic and international findings, we propose the conjecture that Oliceridine may provide better analgesia with fewer adverse effects in the postoperative period of cardiac surgery relative to other opioid analgesic drugs. In this study, we propose to study the analgesic effect of different doses of Oliceridine for pumping in postoperative cardiac surgery patients, its effect on hemodynamics and safety assessment, and we intend to expect to determine the optimal dosing regimen for postoperative cardiac analgesia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xu Qiaolian Nanjing First Hospital
  • Phone Number: 8613813392129
  • Email: xuaqiao1229@163.com

Study Contact Backup

  • Name: Hong Liang Nanjing First Hospital
  • Phone Number: 8615380998663
  • Email: hong3031@163.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postoperative patients undergoing cardiac surgery from November 2024 to October 2025

Exclusion Criteria:

  • body mass index (BMI) > 35 kg/m2 or weight < 40 kg; ② age < 18 years old, or ≥ 80 years old; ③ sleep apnea; ④ opioid allergy; ⑤ use of analgesic drugs for chronic pain; ⑥ prolongation of the Q-T interval; ⑦ serious dysfunction of the liver and kidneys and other organs; ⑧ the presence of postoperative low cardiac output, hemorrhage, vascular paralysis syndrome, etc. Causes circulatory disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Remifentanil
Experimental: High dose Oliceridine
Drug: High dose Oliceridine
High dose Oliceridine
Experimental: Low dose Oliceridine
Drug: Low dose Oliceridine
Low dose Oliceridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CPOT score
Time Frame: 15 minutes, 30 minutes, 1 hour (h), 4 h, 8 h, 12 h, 24 hours (h) after loading dose drugs
15 minutes, 30 minutes, 1 hour (h), 4 h, 8 h, 12 h, 24 hours (h) after loading dose drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KY20240924-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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