Clinical Study of G Protein Biased Μ - Opioid Receptor Agonist Oliceridine for Optimizing Postoperative Analgesia Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Measurement of Total Pain Intensity Difference within 48 Hours (SPID-48)
研究概览
简要总结
Traditional opioid analgesia is a treatment method for moderate to severe pain. However, the use of opioid drugs is not without risks. When treating acute pain, patients may experience hypotension, respiratory depression, hypoxia, nausea and vomiting, irritability, and itching. The purpose of this study is to evaluate the comparison of G protein biased μ - opioid receptor agonist oliceridine and traditional μ - opioid receptor agonist sufentanil in terms of analgesia in patients under general anesthesia.
详细描述
All patients who met the inclusion criteria were randomly divided into two groups based on the use of postoperative analgesic pumps: the sufentanil group and the oliceridine group. The sufentanil group received a treatment regimen of sufentanil 2 µ g · kg-1; The treatment regimen for the oliceridine group is oliceridine 0.4mg · kg-1. The main postoperative observation indicator is the measurement of total pain intensity difference within 48 hours (SPID-48).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age>65 years old
- •ASA Level I-III
- •BMI 18.5-29.9
- •Patients undergoing knee joint surface replacement surgery under general anesthesia
- •Postoperative Patient Controlled Intravenous Analgesia Pump (PCIA) Treatment
- •Possess reading and writing abilities
- •You can sign an informed consent form
排除标准
- •Suffering from chronic pain or mental illness before surgery
- •Unable to communicate due to cognitive impairment or language barriers before surgery
- •Patients who have used opioid drugs three days before surgery
- •Patients with long-term alcohol consumption
- •Abnormal liver and kidney function or dialysis patients
- •Concurrent severe cardiovascular, respiratory, and autonomic neuropathy
- •Participated in clinical studies of other drugs or medical devices in the past 3 months
研究组 & 干预措施
Oliceridine group
Oliceridine 0.4mg · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml. PCIA is set to continuous infusion of 2ml/h, with a single dose of 2ml and a locking time of 15 minutes.
干预措施: Oliceridine (Drug)
Sufentanil group
Sufentanil 2 µ g · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml. PCIA is set to continuous infusion of 2ml/h, with a single dose of 2ml and a locking time of 15 minutes.
干预措施: Sulfentanil (Drug)
结局指标
主要结局
Measurement of Total Pain Intensity Difference within 48 Hours (SPID-48)
时间窗: 48hour
Postoperative pain was evaluated using the NRS Pain Digital Rating Scale at 1, 6, 12, 24, 36, and 48 hours post surgery; Multiply the difference in pain intensity at each post baseline time point within 48 hours (subtracting the pain intensity at a specific post baseline time point from the pain intensity at baseline) by the duration (in hours) of the previous time point, and then add them up.
次要结局
- Adverse reactions(48hour)