Enhanced Postoperative Analgesia and Accelerated Recovery With Oliceridine: A Study on G-Protein Biased μ-Opioid Agonist
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- postoperative pain score
研究概览
简要总结
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.
详细描述
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 1.5 mg for all groups. Depending on the group, the PCA doses are set at 0.1 mg, 0.35 mg, or 0.5 mg, with a lockout interval of 6 minutes. After the initial dose, patients may receive an additional 0.75 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Oliceridine fumarate low dose (Drug)
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.
干预措施: Oliceridine fumarate moderate dose (Drug)
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.
干预措施: Oliceridine fumarate high dose (Drug)
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.
干预措施: morphine (Drug)
结局指标
主要结局
postoperative pain score
时间窗: 6 hour, 24hour, and 48 hour after surgery
The NRS Numerical Pain Evaluation Scale assessed postoperative pain status: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).
次要结局
- Postoperative nausea and vomiting(6 hour, 24 hour, and 48 hour after surgery)
- Postoperative cognitive function(Before surgery, 3 days after surgery)
- Postoperative pulmonary complications(24 hour,72 hour after surgery)
- Flora abundance(One day before surgery and 48 hours after surgery)