Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Emergence agitation
研究概览
简要总结
Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.
In this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.
详细描述
Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery
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
- 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
- 否
入选标准
- •American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
- •undergoing selective thoracotomy
- •weight between 45 and 75kg
- •operation time 2-4 hours
排除标准
- •history of neurologic disease
- •history of chronic analgesics intake
- •history of allergic reactions to the experimental durgs
- •history of renal insufficiency
- •history of hepatic dysfunction
- •history of coagulation disorders
- •women in lactation
- •participating in other studies
研究组 & 干预措施
Group-DEX
Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery
干预措施: dexmedetomidine (Drug)
Group-PLB
Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery
干预措施: saline placebo (Drug)
结局指标
主要结局
Emergence agitation
时间窗: during 0-3 postoperative hours
Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours
次要结局
- Postoperative pain at rest(At 1,3 postoperative hours)
- dosage Dosage of analgesics(during 3 postoperative hours)
- Recovery time(At the moment of the eyes opend when calling the names)
- Postoperative sedation(at 0,1,3 postoperative hours)
- Extubation time(at the moment of extubation)
- Breathing recovery time(when autonomous respiration recovered)
研究者
Fang Luo
Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology
Huazhong University of Science and Technology