RecruitingNot ApplicableNCT06409689

Oliceridine-Enhanced Analgesia and Recovery: A G-Protein Biased μ-Opioid Study

Enhanced Postoperative Analgesia and Accelerated Recovery With Oliceridine: A Study on G-Protein Biased μ-Opioid Agonist


Sponsor

Tongji Hospital

Enrollment

80 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Identifying the lowest effective opioid dose that achieves rapid pain relief while minimizing side effects is a principal objective in postoperative multimodal analgesia strategies. This study aims to determine the optimal analgesic regimen and dosage by assessing the clinical efficacy of oliceridine for postoperative pain management. It also evaluates oliceridine's contribution to accelerated postoperative recovery, examining aspects such as postoperative pulmonary complications, gastrointestinal function, nausea and vomiting, cognitive function, and emotional distress. Furthermore, the study integrates microbiomics and metabolomics to investigate the underlying molecular mechanisms by which oliceridine promotes rapid postoperative recovery. This research will broaden the clinical data and potential applications of oliceridine, addressing gaps in the field and enhancing practical knowledge. Moreover, this is the first time a clinical study combining multiple omics approaches will provide a comprehensive theoretical foundation for its clinical benefits.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • ASA grades 1-2
  • Age > 18 years and < 70 years
  • Laparoscopic upper abdominal surgery under general anesthesia is planned, and the operation time is not more than 4 hours
  • Voluntarily receive postoperative controlled intravenous analgesia
  • Subjects understand and can cooperate with this study
  • Subjects can provide and sign written informed consent prior to conducting investigation-related screening procedures

Exclusion Criteria14

  • BMI>30 kg/m2 or < 19 kg/m2
  • Patients with preoperative use of opioids, acute and chronic pain or hyperalgesia
  • Patients with coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease
  • More severe hepatic and renal insufficiency
  • A history of mental illness or alcoholism
  • A history of alcohol or drug abuse
  • Combined with cranial pressure, intraocular pressure or glaucoma
  • Poorly controlled or untreated hypertension before surgery
  • Preeclampsia or eclampsia
  • Untreated and undertreated hyperthyroidism
  • Combined with autoimmune disease
  • Unable to use the numerical rating scale
  • History of chronic cough
  • Surgery is expected to take more than 4 hours Patients enrolled in other clinical trials within 3 months

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Interventions

DRUGOliceridine fumarate low dose

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

DRUGOliceridine fumarate high dose

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

DRUGOliceridine fumarate moderate dose

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

DRUGmorphine

The first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg.


Locations(1)

Tongji Hospital

Wuhan, Hubei, China

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NCT06409689


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