StressSPOTNCT05782829
Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation (SPOT)
A study testing L-tyrosine supplementation in people with Stress, run by Centre Hospitalier Universitaire de Nice at 1 site in Monaco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stress
- What is being tested?
- L-tyrosine supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteMonaco
- Study dates
- 14 Nov 2023to May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Monaco1 site, 1 recruiting
- Recruiting
CHPG
Monaco, 98000
Bertrand PRUNET, PU-PH, +377 97 98 98 19, bertrand.prunet@chpg.mc
Nicolas RIJO, +37797988445, nicolas.rijo@chpg.mc
About this study
Official title: Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation
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.
- Conditions
- Stress
- Being tested
- L-tyrosine supplementation, Placebo supplementation
- Keywords
- L-Tyrosine supplementation, Perioperative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-tyrosine supplementationDietary supplement
L-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia
Placebo supplementationDietary supplement
Placebo supplementation before surgery for inguinal hernia under general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| L-Tyrosine | Experimental | Not described Receives: Dietary Supplement: L-tyrosine supplementation |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of anxiety status
Anxiety score measured using Y-A STAI
Measured: between the day before surgery and thes day after surgery
Secondary outcomes (6)
Other stress markers variation
anxiety visual analogue scale (from 0 to 10, 10 is worst)
Measured: the day before surgery
Other stress markers variation
anxiety visual analogue scale (from 0 to 10, 10 is worst)
Measured: the day after surgery
Other stress markers variation
heart blood pressure (Systolic and diastolic)
Measured: the day before surgery
Other stress markers variation
heart blood pressure (Systolic and diastolic)
Measured: the day after surgery
Other stress markers variation
cortisol dosage
Measured: the day before surgery
Other stress markers variation
cortisol dosage
Measured: the day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start14 Nov 2023
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, monocentric, double-blind randomized study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782829
- Sponsor's protocol ID
- 17-16
- Acronym
- SPOT
- Status last verified
- Dec 2025
- First submitted
- 13 Feb 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not scheduled