Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Variation of anxiety status
研究概览
简要总结
Patient undergoing surgery is exposed to many stressors: diachronic (gesture anticipation), synchronic (intraoperative aggression) and historical (subject's personality). Reducing the level of stress experienced is a factor for improving the quality of the surgical gesture and the simplicity of the follow-up. The previous methods used were intended to reduce the body's reactivity to aggressions through anaesthesia consultation and L-Tyrosine supplementation. Currently with the progression of outpatient surgery and the need for early rehabilitation, L-Tyrosine supplementation is suppressed to improve recovery. Some patients, however, have a high level of stress that may require anxiolysis when the ideal treatment does not exist (ineffective hydroxyzine, benzodiazepines having many side effects). The strategy of this work is to improve the body's ability to respond to stressors, by administering l-tyrosine with no impact on waking or returning home.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Membership of a social security scheme or equivalent
- •At least 18 years of age
- •Able to express consent
- •Indication of unilateral or bilateral inguinal hernia cure
- •General anaesthesia proposed and retained for inguinal hernia treatment regardless of surgical technique
排除标准
- •Surgical indication for another reason or hernial cure associated with another procedure
- •Smoking estimated at more than 35 pack-years
- •History of psychiatric pathology
- •ASA 3 or 4 according to the American Society of Anesthesiologists classification. As a reminder, an ASA 3 class concerns a patient with a severe but not disabling general disease, and an ASA 4 class concerns a patient with a disabling general disease involving the vital prognosis.
- •ASA 2 and having at least one of the following pathologies or patients treated with -blockers: insulin-dependent diabetes, high blood pressure, heart rhythm disorder, dysthyroidism, progressive neurological disease, long-term benzodiazepines.
- •Starch allergy or intolerance
研究组 & 干预措施
L-Tyrosine
干预措施: L-tyrosine supplementation (Dietary Supplement)
Placebo
干预措施: Placebo supplementation (Dietary Supplement)
结局指标
主要结局
Variation of anxiety status
时间窗: between the day before surgery and thes day after surgery
Anxiety score measured using Y-A STAI
次要结局
- Other stress markers variation(the day after surgery)
- Other stress markers variation(the day before surgery)