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

Study Overview
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Brief Summary
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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.

Official Title
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Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation

Conditions
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Stress

Intervention / Treatment
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* Dietary Supplement: L-tyrosine supplementation
* Dietary Supplement: Placebo supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, monocentric, double-blind randomized study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-Tyrosine<br> | Dietary Supplement: L-tyrosine supplementation<br>* L-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo supplementation<br>* Placebo supplementation before surgery for inguinal hernia under general anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of anxiety status | Anxiety score measured using Y-A STAI | between the day before surgery and thes day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other stress markers variation | anxiety visual analogue scale (from 0 to 10, 10 is worst) | the day before surgery | 
| Other stress markers variation | anxiety visual analogue scale (from 0 to 10, 10 is worst) | the day after surgery | 
| Other stress markers variation | heart blood pressure (Systolic and diastolic) | the day before surgery | 
| Other stress markers variation | heart blood pressure (Systolic and diastolic) | the day after surgery | 
| Other stress markers variation | cortisol dosage | the day before surgery | 
| Other stress markers variation | cortisol dosage | the day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L-Tyrosine supplementation, Perioperative stress