Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient Satisfaction With Anaesthesia Technique
研究概览
简要总结
The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE procedures for solid tumours
详细描述
Pulsed electric current can be used to produce irreversible electroporation (IRE) of cell membranes with resulting cell death. This process has been shown to ablate tumors in animal and human studies. A pulsating direct current of 20 to 50 A and 500 to 3000 V is delivered into metastatic or primary tumors in the liver, kidney, or lung via needle electrodes inserted under computed tomography (CT) or ultrasound guidance. Patients usually require general anesthesia with muscle relaxant. Currently, circa 30 procedures have been done at our institution with good or excellent results. However, several patients have had severe pain postoperatively.
Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. We will evaluate perioperative dexmedetomidine 0.4 µg/kg/hr infusion effects on hemodynamics, anesthetic consumption, and recovery profiles during anesthesia for IRE of solid organs tumours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver or/and pancreas cancer for which IRE procedure is planned
- •signed informed consent form
排除标准
- •patient refusal
- •known allergy to dexmedetomidine or other anaesthesia drugs
- •atrioventricular block grade II or III or other significant cardiac conduction disturbance
- •low blood pressure not responding to treatment
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine infusion during anaesthesia for IRE procedure
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Patient Satisfaction With Anaesthesia Technique
时间窗: At the discharge from post-anaesthesia care room (up to 4 hours after the procedure)
Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extreme
次要结局
- Evaluation of anaesthetic consumption(During anaesthesia)
- Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate(During procedure and up to 4 hours stay at the post-anesthesia care unit)
- Postoperative analgesic requirements(During the first 24 hours after procedure)
- Maximal pain intensity(During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure)
- Description of patient characteristics(During one week before preoperative visit at anaesthesia clinic)
研究者
Egidijus Semenas
Consultant in anaesthesia and intensive care
Uppsala University Hospital