Clinical trial NCT05782829: Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation (SPOT)
Official title: Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Keywords: L-Tyrosine supplementation
Perioperative stress
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, monocentric, double-blind randomized study
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Variation of anxiety status
timeFrame: between the day before surgery and thes day after surgery
Secondary outcomes:
measure: Other stress markers variation
timeFrame: the day before surgery
measure: Other stress markers variation
timeFrame: the day after surgery
measure: Other stress markers variation
timeFrame: the day before surgery
measure: Other stress markers variation
timeFrame: the day after surgery
measure: Other stress markers variation
timeFrame: the day before surgery
measure: Other stress markers variation
timeFrame: the day after surgery
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: CHPG
Study officials:
References: