Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- severity of emergence excitement based on Richmond agitation-sedation scale
研究概览
简要总结
Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. It has been reported that the incidence of postoperative emergence excitement in adults after general anesthesia is 21.3% occurrence.
Many things are mentioned as risk factors for emergence excitement. Among them, excitement after orthognathic surgery (two-jaw) was more common than after other types of surgery. The patients undergoing emergence with nasotracheal intubation after orthognathic surgery may have a sense of suffocation during emergence from anesthesia, which may increase the incidence of emergence excitement.
Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1) compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.
To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement was investigated only in children.
The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence and the severity of the emergence excitement in adults with nasotracheal intubation after orthognathic surgery (two-jaw).
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1 or 2 patients
- •patients scheduled for orthognathic surgery (two-jaw)
排除标准
- •severe cardiovascular disease
- •allergy to dexmedetomidine
- •psychological disease
- •patients who cannot understand Korean
研究组 & 干预措施
saline group
We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing.
干预措施: saline (Drug)
dexmedetomidine group
We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
severity of emergence excitement based on Richmond agitation-sedation scale
时间窗: Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours.
The severity of emergence excitement will be measured up to 10 minutes after extubation based on Richmond agitation-sedation(time of eye opening on command, time of leaving the operation room, 5 minutes after arriving post anesthetic recovery room, 10 minutes after extubation).
次要结局
- emergence time(up to the time of eye opening,an expected average of 30 minutes.)
- coughing grade(up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours.)