Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Time before recovery of hunger after general anesthesia
研究概览
简要总结
Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score) whose validation evaluates patient's ability to return home.
The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic effect of propofol compared to halogenated gases. These studies had neither the power nor the methodology to answer the question. The aim of our study is to evaluate the impact of propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years old women
- •American Society of Anesthesiologists (ASA) score 1-2
- •Affiliated to a social security system
- •Undergoing an ambulatory surgery during more than 15 minutes with general anesthesia and control of upper airways (tracheal intubation or supraglottic mask or facial mask ventilation) for oocytes punction before in vitro fertilization
- •General anesthesia occuring between 8 and 10 am with respect of pre-operative fasting rules
- •APFEL risk score for nausea and vomiting ≤ 2/4
- •Ability to understand and read french
- •Signature of understood consent
排除标准
- •Other surgery than oocytes punction
- •Cognitive dysfunction
- •Undernutrition or risk factor of undernutrition (evolutive neoplasia, chronic alcoholism ...)
- •BMI ≥ 35 kg/m²
- •Eating disorders
- •Diabetes mellitus
- •Chronic treatment with drugs modifying feeding behavior :
- •Benzodiazepines
- •Inhibitors of serotonin reuptake
- •Non respect of pre-operative fasting rules
- •Indication for rapid sequence induction (gastro-oesophageal reflux, absence of gastric emptying ...)
- •Contraindication to propofol (allergia to propofol, soybean or peanuts, past history of propofol infusion syndrome, unstable cardiovascular disease) or to sevoflurane (past history of malignant hyperthermia, epilepsy or liver disorders after administration of a halogenated anesthetic)
- •Pregnant or breastfeeding woman
- •Involvement in another clinical trial under 4 previous weeks
研究组 & 干预措施
propofol
Hypnotic used in this arm is exclusively intra-venous propofol.
干预措施: propofol (Drug)
sevoflurane
Hypnotic used in this arm is exclusively inhaled sevoflurane.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Time before recovery of hunger after general anesthesia
时间窗: 1-4 hours
Time before appearance of of hunger (evaluated by a score above 50/100 mm on analogic visual scale) after the end of hypnotic administration (propofol or sevoflurane).
次要结局
- Post operative nausea and vomiting(1-4 hours)
- Feeding comfort(1-4 hours)
- Change in plasmatic insulin level(0-3 hours)
- Validation of Chung score(1-4 hours)
- Change in plasmatic leptin level(0-3 hours)
- Change in plasmatic ghrelin level(0-3 hours)