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

Official title

Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation

Overview

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.

Interventions

• Dietary supplement L-tyrosine supplementation
  L-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia
• Dietary supplement Placebo supplementation
  Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Primary outcome measures

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

Secondary outcome measures (6)

• Other stress markers variation [Time frame: the day before surgery]
• Other stress markers variation [Time frame: the day after surgery]
• Other stress markers variation [Time frame: the day before surgery]
• Other stress markers variation [Time frame: the day after surgery]
• Other stress markers variation [Time frame: the day before surgery]
• Other stress markers variation [Time frame: the day after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Monaco · 1 center

• CHPG — Monaco

Identifiers

NCT: NCT05782829 · 17-16

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗