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

Not Applicable

Not yet recruiting

• Conditions: Stress
• Interventions: Dietary Supplement: L-tyrosine supplementation; Dietary Supplement: Placebo supplementation

• Registration Number: NCT05782829
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24
• Study Start: 2023-04
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Tyrosine	L-tyrosine supplementation	-
Placebo	Placebo supplementation	-

Primary Outcome Measures

Name	Time	Method
Variation of anxiety status	between the day before surgery and thes day after surgery	Anxiety score measured using Y-A STAI

Secondary Outcome Measures

Name	Time	Method
Other stress markers variation	the day after surgery	cortisol dosage

Trial Locations

Locations (1)

CHPG; 🇲🇨 Monaco, Monaco