NCT05782829

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

November 14, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

2.4 years

First QC Date

February 13, 2023

Last Update Submit

December 2, 2025

Conditions

Stress

Keywords

L-Tyrosine supplementationPerioperative stress

Outcome Measures

Primary Outcomes (1)

  • Variation of anxiety status

    Anxiety score measured using Y-A STAI

    between the day before surgery and thes day after surgery

Secondary Outcomes (6)

  • Other stress markers variation

    the day before surgery

  • Other stress markers variation

    the day after surgery

  • Other stress markers variation

    the day before surgery

  • Other stress markers variation

    the day after surgery

  • Other stress markers variation

    the day before surgery

  • +1 more secondary outcomes

Study Arms (2)

L-Tyrosine

EXPERIMENTAL
Dietary Supplement: L-tyrosine supplementation

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo supplementation

Interventions

L-tyrosine supplementationDIETARY_SUPPLEMENT

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

L-Tyrosine
Placebo supplementationDIETARY_SUPPLEMENT

Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHPG

Monaco, 98000, Monaco

RECRUITING

Central Study Contacts

Bertrand PRUNET, PU-PH

CONTACT

+377 97 98 98 19bertrand.prunet@chpg.mc

Nicolas RIJO

CONTACT

+377 97 98 84 45nicolas.rijo@chpg.mc

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: prospective, monocentric, double-blind randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 24, 2023

Study Start

November 14, 2023

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Not scheduled

Locations

MO(1)