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RecruitingNCT05782829SPOTUpdated Dec 8, 2025

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

An interventional study of L-tyrosine supplementation and Placebo supplementation in Stress, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in Monaco. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stress

Keywords

  • L-Tyrosine supplementation
  • Perioperative stress
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    L-Tyrosine

    Dietary Supplement: L-tyrosine supplementation

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo supplementation

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

05

What researchers measure

Primary outcomes

  1. Variation of anxiety status

    Anxiety score measured using Y-A STAI

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

Secondary outcomes

  1. Other stress markers variation

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

    Time frame: the day before surgery

  2. Other stress markers variation

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

    Time frame: the day after surgery

  3. Other stress markers variation

    heart blood pressure (Systolic and diastolic)

    Time frame: the day before surgery

  4. Other stress markers variation

    heart blood pressure (Systolic and diastolic)

    Time frame: the day after surgery

  5. Other stress markers variation

    cortisol dosage

    Time frame: the day before surgery

  6. Other stress markers variation

    cortisol dosage

    Time frame: the day after surgery

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No — Not scheduled

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05782829
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Mar 24, 2023
Start date
Nov 14, 2023
Primary completion
Apr 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Dec 8, 2025

Study contacts

Bertrand PRUNET, PU-PH
Contact
bertrand.prunet@chpg.mc
+377 97 98 98 19
Nicolas RIJO
Contact
nicolas.rijo@chpg.mc
+377 97 98 84 45

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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