Comparison of Epidural Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine on Postoperative Pain Level, Analgesic Consumption and Oxidative Stress in Thoracic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in postoperative pain level using visual analogue scale
研究概览
简要总结
The aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery
详细描述
The aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery.
Investigation will include patients between 30-70 years undergoing thoracic surgery due to malignant process of lung or oesophagus.
Patients are divided in two groups: epidural administration of 0.375% ropivacaine with 1 mcg/kg dexmedetomidine (group 1) and epidural administration of 0.375% ropivacaine with 8 mg dexamethasone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing thoracic surgery due to malignant process of lung or oesophagus ASA (American Society of Anesthesiologists) status I-III
排除标准
- •neurological or psychiatric disease
- •corticosteroid therapy
- •anamnesis of myocardial infarct within last 6 months
- •severe aortic stenosis
- •kidney insufficiency
- •liver insufficiency
- •coagulation disorders
研究组 & 干预措施
Dexmedetomidine
1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Dexamethasone
8 mg dexamethasone added to 8 ml 0,375% ropivacaine
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
结局指标
主要结局
Change in postoperative pain level using visual analogue scale
时间窗: Before operation, 1 hour, 2 hour, 6 hour and 24 hour after operation
Change in baseline postoperative pain level measured before operation, and then at 1h, 2h, 6h and 24h after operation using visual analogue scale. Visual analogue scale is numerical scale in range from 1-10, assessing pain level. Minimum score is 1, which represents- no pain to maximum score 10 which represents- the worst pain ever experienced.
次要结局
- oxydative stress level(24 hour)
- analgesic consumption(24 hour)
研究者
Jasminka Persec, MD, PhD
Assist Prof MD PhD
University Hospital Dubrava