A Comparison of Dexmedetomidine and Epidural Anesthesia Under General Anesthesia in Patients Undergoing Gastrectomy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cardiovascular Parameters: Heart rate, blood pressure and ECG ;Parameters on stress response:norepinephrine (NE), epinephrine ( E)
研究概览
简要总结
Clinically, combining epidural with general anaesthesia may confer many advantages to patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis, spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However, establishing epidural anesthesia is not without risks and contraindications, including refusal by the patient, technical failure, unintentional dural puncture, waist and back pain and local anaesthetic toxicity. When neurologic complications do occur, the resulting morbidity and mortality is considerable. Dexmedetomidine is a potent α2-adrenoceptor agonist with an 8 times greater affinity for α2-adrenoceptors than clonidine. This class of agent is known to have sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate the stress response associated with surgery.1 Unlike epidural anaesthesia, dexmedetomidine is easy to administer and no potential for neurological damage. The investigators hypothesize that the dexmedetomidine reduces the stress response of surgery to the similar extent to epidural anaesthesia when used in conjunction with a standard general anaesthesia for abdominal surgery.
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
- Double (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
- 否
入选标准
- •No contraindication to epidural or dexmedetomidine
- •First time surgery for current conditions
- •Not on chronic pain medications or sedative
排除标准
- •.The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
- •The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
- •The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine
- •The subject has know central nervous system disease or neurological impairment
- •The subject is an ASA classification of 3 or greater
研究组 & 干预措施
dexmedetomidine
Drug:dexmedetomidine,dexmedetomidine 1.0μg/kg intravenous injection within 15 minutes before the induction of general anesthesia and followed by Dex 0.4μg/kg/h until 40min before the end of surgery
干预措施: dexmedetomidine (Drug)
epidural
Epidural:continuous epidural block (T8-9) 4 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
Cardiovascular Parameters: Heart rate, blood pressure and ECG ;Parameters on stress response:norepinephrine (NE), epinephrine ( E)
时间窗: pre-administration of Dex or epidural anesthesia,intubation, 3 min after intubation , immediately after incision, immediately after the initiation of celiac exploration, 1 h after operation,extubation
次要结局
- Anesthetics consumption: propofol and remifentanil consumption(during operation)
- anesthesia recovery :the time of eye opening, side effects such as nausea, vomiting and post-anaesthetic shivering, VAS, first exhaust time, hospitalization time(up to 48 hours)
研究者
Yun Li
Head of department of Anesthesiology in the Second Affiliated Hospital of Anhui Medical University
Anhui Medical University