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NCT Number: NCT05782829

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

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.

Recruiting

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Key information

Conditions

Stress

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-tyrosine supplementation

Dietary Supplement

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

Placebo supplementation

Dietary Supplement

Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Primary outcomes

  1. Variation of anxiety status

    Time frame: between the day before surgery and thes day after surgery

    Anxiety score measured using Y-A STAI

Secondary outcomes

  1. Other stress markers variation

    Time frame: the day before surgery

    anxiety visual analogue scale (from 0 to 10, 10 is worst)

  2. Other stress markers variation

    Time frame: the day after surgery

    anxiety visual analogue scale (from 0 to 10, 10 is worst)

  3. Other stress markers variation

    Time frame: the day before surgery

    heart blood pressure (Systolic and diastolic)

  4. Other stress markers variation

    Time frame: the day after surgery

    heart blood pressure (Systolic and diastolic)

  5. Other stress markers variation

    Time frame: the day before surgery

    cortisol dosage

  6. Other stress markers variation

    Time frame: the day after surgery

    cortisol dosage

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand PRUNET, PU-PH

CONTACT

[email protected]

+377 97 98 98 19

Nicolas RIJO

CONTACT

[email protected]

+377 97 98 84 45

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation

Acronym: SPOT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2023
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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