Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 6
- 主要终点
- 30 min DSST ratio
研究概览
简要总结
Obesity is increasing in France, resulting in an increased demand for bariatric surgery. However obesity also alters physiopathological pathways and the pharmacokinetics of anesthestic agents. The investigators objective is to compare, among morbidly obese patients, the immediate and intermediary emergence kinetics after balanced anesthesia using remifentanil associated either with desflurane (reference arm) or with xenon (experimental arm).
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
- Double (Participant, 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 Anesthesiologists (ASA) I to III
- •requires bariatric surgery
- •body mass index (BMI) >= 35 kg/m2
- •patient speaks and writes French
- •patient has signed consent form
- •patient enrolled in a social security program
排除标准
- •patient refuses to sign consent
- •ASA IV or more
- •patient is pregnant or breastfeeding
- •history of hyperthermy (or suspicion, or family history thereof)
- •history of liver disease, icterus, unexplained fever, or eosinophilia after administration of a halogen anesthesia
- •patient has symptomatic gastro-oesophagean reflux
- •patient has hypersensitivity to one or more of the following substances: propofol, remifentanil, celocurine, cisatracurium, rocuronium, desflurane, xenon, paracetamol, ketoprofen, nefopam, tramadol
- •patient has obstructive respiratory failure (chronic obstruction pneumopathy, asthma) or has heart disease with severly altered cardiac function
- •patient has high intracranial pressure
- •patient requires high concentrations of oxygen (fio2>40%)
- •patient has a neuro-sensorial deficient which prevents reading, writing, or response to simple oral commands (severe deafness, language impairment...)in the absence of a prothesis
- •patient has a psychiatric pathology, or chronically consumes alcohol or other mind-altering substance
- •patient has had general anesthesia in the last 15 days
- •patient under guardianship
- •impossible to correctly communicate information to the patient
- •absence of efficient contraception for women of childbearing age
- •participation in another study within the last 3 months
研究组 & 干预措施
Reference - desflurane
The patients in this group will undergo anesthesia using remifentanil associated with desflurane.
干预措施: Desflurane (Drug)
Experimental - xenon
The patients in this group will undergo anesthesia using remifentanil associated with xenon
干预措施: Xenon (Drug)
结局指标
主要结局
30 min DSST ratio
时间窗: 30 minutes post-op
(the number of correct responses to a Digit Symbol Substitution Test \[DSST\] 30 minutes after surgery) / (the number of correct responses to a Digit Symbol Substitution Test the night before the surgery)
次要结局
- 60 min DSST test(60 minutes post-op)
- Time to Aldrete score of 10(Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10)
- 90 min DSST test(90 min post-op)
- Quality of recovery score(Day 1 post-op)