Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery：a Randomized Control Double Blinded Clinical Trail
试验速览
- 阶段
- 不适用
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Emergence agitation incidence
研究概览
简要总结
Emergence agitation is one of the common postoperative complications after functional endoscopic sinus surgery（FESS). The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus Surgery.
详细描述
Butorphanol is a mixed agonist-antagonist opioid with strong κappa-receptor agonist and weak mu-receptor antagonist activity. It is commonly used for the management of cancer, postoperative, gynecologic, and obstetric pain. Additionally, Butorphanol has less respiratory depression and sedation effects, which make it may become a good medicine to alleviate the agitation. However, there is no clinical evidence to confirmation of such effectiveness of butorphanol. The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus 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
- •Age >=18 years,<=65years;
- •height 150-180 cm;
- •weight 55-80 kg;
- •Signed the inform consent
- •American Society of Anesthesiologists classification I to II
- •Select to functional endoscopic sinus surgery
排除标准
- •Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
- •Several audition or vision disorder;
- •Unwillingness to comply with the protocol or procedures.
- •Can not communicated with Chinese Mandarin
- •Existing bradycardiac arrhythmia（Heart rate <60 bpm for any reasons）
- •Existing gastrointestinal ulcer
- •Existing urinary incontinence
- •Existing asthma or chronic obstructive pulmonary disease
- •Allegory to Butorphanol
研究组 & 干预措施
Butorphanol
Butorphanol 20ug/kg , anesthesia induction，Intravenous injection
干预措施: Butorphanol (Drug)
Placebo
Normal saline 5ml ， anesthesia induction，Intravenous injection
干预措施: Placebos (Drug)
结局指标
主要结局
Emergence agitation incidence
时间窗: 1 hour in the post anesthesia care unite(PACU)
Emergence agitation incidence
次要结局
- MAP(1 hour in the post anesthesia care unite(PACU))
- HR(1 hour in the post anesthesia care unite(PACU))
- quality of recovery -40 questionnaire(24h after operation)
研究者
Xiaorong Huai
resident physician
RenJi Hospital