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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-14

Study Completion Date

2026-05-31

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.

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Detailed Description

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Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, monocentric, double-blind randomized study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L-Tyrosine

Group Type EXPERIMENTAL

L-tyrosine supplementation

Intervention Type DIETARY_SUPPLEMENT

L-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia

Placebo

Group Type PLACEBO_COMPARATOR

Placebo supplementation

Intervention Type DIETARY_SUPPLEMENT

Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Interventions

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L-tyrosine supplementation

L-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia

Intervention Type DIETARY_SUPPLEMENT

Placebo supplementation

Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No