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

Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05782829
Acronym
SPOT
Enrollment
150
Registered
2023-03-24
Start date
2023-11-14
Completion date
2026-05-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Keywords

L-Tyrosine supplementation, Perioperative stress

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.

Interventions

DIETARY_SUPPLEMENTL-tyrosine supplementation

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

DIETARY_SUPPLEMENTPlacebo supplementation

Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

prospective, monocentric, double-blind randomized study

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Variation of anxiety statusbetween the day before surgery and thes day after surgeryAnxiety score measured using Y-A STAI

Secondary

MeasureTime frameDescription
Other stress markers variationthe day before surgeryanxiety visual analogue scale (from 0 to 10, 10 is worst)

Countries

Monaco

Contacts

Primary ContactBertrand PRUNET, PU-PH
bertrand.prunet@chpg.mc+377 97 98 98 19
Backup ContactNicolas RIJO
nicolas.rijo@chpg.mc+377 97 98 84 45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026