Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery
Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tapentadol in Patients Undergoing Bariatric Surgery
This single-center, stratified randomized double-blind trial tests tegileridine, a new pain drug, for pain relief after weight-loss surgery. Researchers will compare tegileridine with standard opioid pain medicine.
Eligible patients having bariatric surgery will be randomly assigned to one of the two treatment groups. Patients and study teams will not know which treatment each participant receives. Participants will be grouped based on whether they have obstructive sleep apnea (OSA).
The primary measurement is postoperative recovery quality in the first 24 hours after surgery using the QoR-15 survey. The study will also track pain scores, rescue pain medication use, and drug side effects for 7 days after surgery.
There is no guaranteed benefit for participants. Study pain medicines may cause side effects. Doctors will provide rescue treatment for uncontrolled pain.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Meikun Wang, MD
- 电话号码：+8613578774973
- 邮箱：wangmkjdyy@jlu.edu.cn
学习地点
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Jilin
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Changchun、Jilin、中国、130000
- 招聘中
- The First Hospital of Jilin University
-
接触：
- Meikun Wang, MD
- 电话号码：8613578774973
- 邮箱：wangmkjdyy@jlu.edu.cn
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 to 65 years old
- Scheduled for elective bariatric surgery
- American Society of Anesthesiologists (ASA) physical status I, II or III
- Able to understand and complete the QoR-15 questionnaire
- Provide written informed consent to participate in the study
Exclusion Criteria:
- Known allergy or hypersensitivity to opioids, tegileridine or sufentanil
- Severe hepatic or renal dysfunction
- Preoperative chronic opioid use
- History of severe respiratory disease except obstructive sleep apnea
- Pregnant or breastfeeding women
- Participants who cannot complete postoperative follow-up
- Participation in another interventional clinical trial within 30 days before surgery
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Tegileridine Group
|
Tegileridine will be given to participants for postoperative pain relief after bariatric surgery. |
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有源比较器：Standard Opioid Group
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Sufentanil, a standard opioid analgesic, will be given to participants to manage postoperative pain following bariatric surgery. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery
大体时间：24 hours after bariatric surgery
|
The Quality of Recovery-15 (QoR-15) is a validated questionnaire used to assess the quality of postoperative recovery. The total score ranges from a minimum of 0 to a maximum of 150. A higher score indicates a better quality of recovery. |
24 hours after bariatric surgery
|
合作者和调查者
出版物和有用的链接
一般刊物
- Wang T, Wang Y, Xie H, Wu Z, Yu S, Ou Y, Xu M, Jiang W, Ge L, Gao J, Wang Q, Gao H, Huang Y, Zhao P, Yu Y, Huang H, Ren J, Xia Z, Zhang J, Yu J, Chen X. Tegileridine for moderate-to-severe acute pain following abdominal surgery: A randomized, double-blind, phase 3 clinical trial. Cell Rep Med. 2025 Dec 16;6(12):102477. doi: 10.1016/j.xcrm.2025.102477. Epub 2025 Dec 8.
- GBD 2021 Adult BMI Collaborators. Global, regional, and national prevalence of adult overweight and obesity, 1990-2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study 2021. Lancet. 2025 Mar 8;405(10481):813-838. doi: 10.1016/S0140-6736(25)00355-1. Epub 2025 Mar 3.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.