Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409689
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-07
Brief Title:
Oliceridine-Enhanced Analgesia and Recovery A G-Protein Biased μ-Opioid Study
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
Enhanced Postoperative Analgesia and Accelerated Recovery With Oliceridine A Study on G-Protein Biased μ-Opioid Agonist
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 oliceridines 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
Detailed Description:
This study selects 80 elective patients slated for upper abdominal laparoscopic surgery under general anesthesia classified as ASA I-II These patients are randomly allocated into four groups Oliceridine low dose OⅠ medium dose OⅡ and high dose OⅢ and a Morphine M group The postoperative analgesic protocol includes a universal loading dose of 15 mg for all groups Depending on the group the PCA doses are set at 01 mg 035 mg or 05 mg with a lockout interval of 6 minutes After the initial dose patients may receive an additional 075 mg per hour as needed with a daily ceiling of 27 mg for Oliceridine In the Morphine group the loading dose is 4 mg with a PCA dose of 1 mg and similar lockout allowing 2 mg per hour post-loading capped at 60 mg daily Outcomes to monitor include systolic and diastolic blood pressures heart rate oxygen saturation and respiratory rate at 6 24 and 48 hours postoperatively pain levels using the NRS scale nausea and vomiting via the VAS score and pulmonary complications evaluated by EPCO standards at specified intervals Gastrointestinal function is assessed using the I-FEED score and mental health through the HADS scale preoperatively and 48 hours post-surgery Cognitive function is evaluated using the MMSE scale preoperatively and 72 hours postoperatively Patient fecal samples are collected pre- and 48 hours post-surgery for microbial and metabolomic analyses to identify potential molecular benefits of Oliceridine informed by its G-protein biased pharmacology The study also uses statistical methods to compare microbiological outcomes and correlate these with clinical presentations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None