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
- 88 participants
- Where
- 1 siteMonaco
- Study dates
- 14 Nov 2023to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
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 completion15 Apr 2026
- Study completion15 Apr 2026
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.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 88 participants (actual)
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
- Nov 2026
- First submitted
- 13 Feb 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not scheduled
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation
- ClinicalTrials.gov ID
- NCT05782829
- Acronym / sponsor ID
- SPOT / 17-16
- Conditions
- Stress
- Keywords
- L-Tyrosine supplementation, Perioperative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- prospective, monocentric, double-blind randomized study
| Arm | Type | Receives |
|---|---|---|
| L-Tyrosine | Experimental | Dietary Supplement: L-tyrosine supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-tyrosine supplementationL-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia | Dietary supplement | L-Tyrosine |
| Placebo supplementationPlacebo supplementation before surgery for inguinal hernia under general anaesthesia | Dietary supplement | Placebo |
Primary outcome
Variation of anxiety status
Time frame: between the day before surgery and thes day after surgery
Anxiety score measured using Y-A STAI
6 secondary outcomes
Other stress markers variation
Time frame: the day before surgery
Other stress markers variation
Time frame: the day after surgery
Other stress markers variation
Time frame: the day before surgery
Other stress markers variation
Time frame: the day after surgery
Other stress markers variation
Time frame: the day before surgery
Other stress markers variation
Time frame: the day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Not scheduled
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-tyrosine supplementation in people with Stress, run by Centre Hospitalier Universitaire de Nice at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of anxiety status (time frame: between the day before surgery and thes day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.