The Effect of Dexmedetomidine on Agitation and Delirium in Patients After Free Flap Reconstructive Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Agitation in PACU
研究概览
简要总结
Reconstruction using microvascular free tissue flap has been an important management in patients with maxillofacial tumor. It is often characterised as long operation time, more traumatic and require restriction of patient's head movement postoperatively in order to prevent disruption of microvascular anastomosis. Agitation and delirium are common in patients with free flap surgery, which may lead to serious consequences such as self extubation, injury or even failure of the flap.
Dexmedetomidine is a sedative and co-analgesic drug with high specificity for α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on preventing delirium has not been proved.
The investigators hypothesized that the use of Dexmedetomidine would reduce emergence agitation and prevent delirium in patients after free flap 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing selected maxillofacial surgery with free flap reconstruction
- •American Society of Anesthesiologist(ASA) classification I and II
排除标准
- •bradycardia (< 50 bpm)
- •severe heart block
- •low blood pressure(SBP<80mmHg)
- •Known allergy to alpha 2 agonists
研究组 & 干预措施
dexmedetomidine
Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
干预措施: Dexmedetomidine (Drug)
control
Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
干预措施: Saline placebo (Drug)
结局指标
主要结局
Agitation in PACU
时间窗: participants will be followed for the duration of PACU stay, an expected average of 12 hours
Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)\>=5.
次要结局
- Postoperative Delirium(on each of the 5 days postoperatively)
研究者
Yang Xudong
vice director of the department of Anesthesiology
Peking University