Comparison of the Effects of Dexmedetomidine and Ketamine Infusion on the Inflammatory Response in Liver Resection: a Randomized Double-blind Placebo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Level of Pentraxin in ng/mL
研究概览
简要总结
Resection is being performed with increasing frequency in the treatment of surgical diseases of the liver. Ischemia-reperfusion injury is a major cause of liver injury occurring during surgical procedures, including hepatic resection and liver transplantation. Dexmedetomidine and ketamine, which are frequently used in anesthesia practice, also have strong anti-inflammatory capacity. The primary aim of this study is to investigate the effect of iv low-dose ketamine and dexmedetomidine infusion on inflammation in liver resection surgery, and the secondary aim is to determine its effect on pain scores.
详细描述
General anesthesia will apply to all patients. Group 1 (Control Group, n=15); After intubation, saline infusion will be started. The control group will also be infused with the same volume of saline.
Group 2 (Ketamine Group, n=15); After intubation, the patient will be started on ketamine infusion at a low dose of 0.25mg/kg/hour.
Group 3 (Dexmedetomidine Group, n=15); After intubation, the patient will be infused at a low dose of 1 mg/kg for the first 10 minutes, then 0.5 mg/kg/hour.
For biochemical examination, blood will be taken for PEDF (Pigment epithelium-derived factor), Pentraxin 3, Serum amyloid A at the 1st and 12th postoperative hour. AST, ALT, GGT, LDH, bilirubin, CRP and hemogram results, which are routinely checked during these hours, will be recorded.
All the patients were administered 1000 mg iv paracetamol 30 minutes before the surgery ended, and was repeated every 6 hours following the surgery.The postoperative analgesia was evaluated by using VAS(Visual Analogue Scale).The PCA (Patient Controlled Analgesia) device was programmed at 10 μcq concentration with loading dose 50 μcq, 15-minute lock time, 25 μcq bolus without basal infusion, and this was continued for 24 hours in the postoperative recovery room.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA (American Society of Anaesthesiologists) I-II-III group who will undergo liver resection surgery,
- •no known history of heart, kidney, hematological disease, peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
- •who agreed to participate in the study
排除标准
- •Patients with underlying serious cardiovascular disease,
- •patients who cannot cooperate, patients who are allergic to one of the drugs to be used
- •patients who do not want to participate
结局指标
主要结局
Level of Pentraxin in ng/mL
时间窗: After the Operation
Pentraxin levels of the patients in both groups will be measured in terms ng/mL with Enzyme-Linked ImmunoSorbent Assay technique after the liver resection postoperatively.
Serum Amyloid A level in mcg/ml
时间窗: After the operation
Serum Amyloid A level of all patients in both groups will be measured in terms of mcg/ml with Enzyme-Linked ImmunoSorbent Assay technique after the liver resection postoperatively.
次要结局
未报告次要终点
研究者
irem ateş
Associate Professor as the Principal Investigator
Ataturk University