Anesthetic Advantages of Dexmedetomidine Compared With Nitroglycerin for Hypotensive Anesthesia in Orthognathic Surgery. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- amount of intraoperative fentanyl
研究概览
简要总结
The aim of this study was to evaluate the positive anesthetic properties such as reduce intraoperative analgesic requirement, time to extubation and recovery, and early postoperative pain of dexmedetomidine used as a hypotensive agent compared with nitroglycerin.
详细描述
The subject included the healthy patients who underwent orthognathic surgery and gave written the informed consent. The sample size was calculate from the amount of fentanyl use in orthognathic surgical case and difference more 30% was significant. Randomization was done by random number table to 2 groups. Both groups received standardized controlled hypotensive anesthesia and surgery. D group used dexmedetomidine as the hypotensive drug and N group use nitroglycerin. The main outcome were the amount of fentanyl use, time to eye opening, follow simple command, extubation, early postoperative pain, and early postoperative amount of pain killer. All recorded by anesthesiologist on data sheet.
compare statistical analysis used compare mean by unpaired student t test.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who undergo bimaxillary surgery physical status I according to the classification of the American Society of Anesthesiologist age 18-45 years
排除标准
- •systemic diseases not given informed consent
研究组 & 干预措施
dexmedetomidine
Intraoperative controlled hypotension by dexmedetomidine
干预措施: Dexmedetomidine (Drug)
nitroglycerin
Intraoperative controlled hypotension by nitroglycerin
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
amount of intraoperative fentanyl
时间窗: intraoperatve period
Record the amount of fentanyl used in the operation.
次要结局
- time to eye opening(emergence of anesthesia)
- time to follow verbal command(emergence of anesthesia)
- time to extubation(emergence of anesthesia)
- postoperative pain score at 30 minute(early postoperative period)
- postoperative pain score at 60 minute(early postoperative period)
- amount of pethidine(early postoperative period (first 2 hours))
研究者
Duangdee Rummasak
department of oral and maxillofacial surgery, faculty of dentistry
Mahidol University