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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Hui Xu
huixu@tjh.tjmu.edu.cn
+8613971001596
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 80
Treatments
Experimental: Oliceridine fumarate low dose group
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; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours.
Experimental: Oliceridine fumarate medium dose group
The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35mg, 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; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours.
Experimental: Oliceridine fumarate high dose group
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; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours.
Experimental: Morphine group
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. The duration of PCA analgesia was 48 hours.
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital

This content was sourced from clinicaltrials.gov