Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- VAS score 2 hours after operation
研究概览
简要总结
Traditional opioid analgesia is a method to treat moderate to severe pain. However, the use of opioids is not without risks. When treating acute pain, patients may have hypotension, respiratory depression, hypoxia, nausea and vomiting, irritability and pruritus. The aim of this study was to evaluate the analgesic effect and safety of g-protein-biased μ - opioid receptor agonists Oliceridine and oxycodone in vitrectomy.
详细描述
a total of 120 patients scheduled for vitrectomy were randomly divided into Oliceridine group (n = 60) and oxycodone group (n = 60). The main outcome measure was visual analogue scale (VAS) at 2 hours after operation, and the secondary outcome measures included intraoperative analgesic drug addition, VAS scores at 6 and 24 hours after operation, respiratory depression (oxygen saturation < 90%) and incidence of adverse reactions (nausea, vomiting, dizziness).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years old, ASA Ⅰ - Ⅱ (the age of patients with vitreous surgery can be relaxed to 75 years old, and serious systemic diseases need to be excluded);
- •Vitrectomy with local anesthesia (retrobulbar / peribulbar block) combined with intravenous sedation and analgesia (such as maculopathy, retinal detachment, etc.);
- •Preoperative VAS score ≤ 3, can cooperate with pain and sedation score;
- •Signed informed consent.
排除标准
- •Be allergic to test drugs or opioids, or have a history of opioid abuse;
- •Severe cardiopulmonary disease (such as heart failure, COPD), liver and kidney dysfunction (alt/ast > 3 times normal, creatinine > 177 μ mol/l);
- •Glaucoma (avoiding the risk of fluctuation of intraocular pressure), sinus bradycardia (< 50 beats / min, preventing aggravation of oculo cardiac reflex);
- •Used analgesic / sedative drugs within 24 hours before surgery;
- •Those who are unable to cooperate due to mental illness or cognitive impairment.
研究组 & 干预措施
Oliceridine group
Intraoperative analgesia: Oliceridine 0.015mg/kg
干预措施: Oliceridine (Drug)
Oxycodone group
Intraoperative analgesia oxycodone 0.04mg/kg
干预措施: Oxycodone (Drug)
结局指标
主要结局
VAS score 2 hours after operation
时间窗: From enrollment to the end of treatment at 1 day
Postoperative 2-hour VAS score (total score of 10, 0 indicates no pain, and 10 indicates the most severe unbearable pain)
次要结局
- Adverse reactions(From enrollment to the end of treatment at 1 day)