ClinicalTrials.gg
CompletedNCT05782829SPOTUpdated Nov 3, 2026

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. Completed at 1 site in Monaco. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

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

Updated Nov 3, 2026Now CompletedStudy completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
88
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

In context

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

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

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

06

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

07

Study locations

1 site
  • CHPG
    Monaco, 98000, Monaco
08

References and documents

Individual participant data

Plan to share: No — Not scheduled

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Nov 3, 2026
Study completion
May 2026→Apr 15, 2026 (actual)
Nov 3, 2026
Enrollment
150 (estimated)→88 (actual)
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Recruiting→Completed
    Study completion May 2026→Apr 15, 2026 (now actual)
    Enrollment 150 (estimated)→88 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05782829
Responsible party
Sponsor
First posted
Mar 24, 2023
Start date
Nov 14, 2023
Primary completion
Apr 15, 2026
Completion
Apr 15, 2026
Last update
Nov 3, 2026

Oversight

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

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