NCT06743802招募中4 期
The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery: a Randomized Controlled Trial
The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2025年1月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- The incidence of chronic postsurgical pain
研究概览
简要总结
This study aimed to assess the effectiveness of Coenzyme Q10 in preventing both acute and chronic pain following thoracoscopic surgery, with a focus on its potential benefits in reducing the incidence and severity of pain.
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
- Triple (Participant, 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
- 否
入选标准
- •Aged 18-75 years;
- •American Society of Anesthesiology (ASA) physical status classification I-III;
- •Scheduled for elective lung resection surgery under thoracoscopy;
- •Voluntarily opting for patient-controlled intravenous analgesia;
- •Willing to participate in this trial after consultation with the patient or their family and signing the informed consent form.
排除标准
- •History of previous thoracotomy or thoracoscopic surgery;
- •Patients converted to open thoracotomy intraoperatively;
- •Severe hepatic or renal dysfunction;
- •History of substance abuse;
- •Pregnancy or breastfeeding;
- •History of chronic pain;
- •Use of coenzyme Q10 for more than one month;
- •Allergy to coenzyme Q10;
- •Patients unable to communicate or cooperate.
研究组 & 干预措施
Coenzyme Q10
Experimental
干预措施: Coenzyme Q10 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
The incidence of chronic postsurgical pain
时间窗: from the end of surgery to 3 months after surgery
次要结局
- The incidence of acute postoperative pain with a score ≥4(from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.)
- The severity of acute postoperative pain(from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.)
- The severity of chronic postsurgical pain(from the end of surgery to 3 months after surgery)
- The incidence of neuropathic pain(from the end of surgery to 3 months after surgery)
- The frequency of postoperative rescue analgesic use(from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.)
- The dose of analgesic use(from the end of surgery to 6 hours,12 hours, 24 hours and 48 hours after surgery.)
- The quality of recovery score at 3 days Postoperatively(from the end of surgery to 3 days.)
- Health related quality of life score at 3 months Postoperatively(from the end of surgery to 3 months after surgery.)
- Postoperative length of hospital stay(from end of surgery to about 3 to 7 days after surgery.)
- The incidence of adverse reactions(From admission to 3 month post-discharge)
研究者
研究点 (1)
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