Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation (SPOT)

Официальное название

Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation

Обзор

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.

Вмешательства

• Пищевая добавка L-tyrosine supplementation
  L-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia
• Пищевая добавка Placebo supplementation
  Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Первичные конечные точки

• Variation of anxiety status [Срок оценки: between the day before surgery and thes day after surgery]

Вторичные конечные точки (6)

• Other stress markers variation [Срок оценки: the day before surgery]
• Other stress markers variation [Срок оценки: the day after surgery]
• Other stress markers variation [Срок оценки: the day before surgery]
• Other stress markers variation [Срок оценки: the day after surgery]
• Other stress markers variation [Срок оценки: the day before surgery]
• Other stress markers variation [Срок оценки: the day after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Monaco · 1 центр

• CHPG — Monaco

Идентификаторы

NCT: NCT05782829 · 17-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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