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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress
• Intervention / Treatment: Dietary supplement: L-tyrosine supplementation; Dietary supplement: Placebo supplementation

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle ROUQUETTE-VINCENTI, MD, PhD; Phone Number: +377 97 98 98 19; Email: isabelle.rouquette-vincenti@chpg.mc
• Study Contact Backup: Name: Nicolas RIJO; Phone Number: +377 97 98 84 45; Email: nicolas.rijo@chpg.mc

Study Locations

• Monaco
  • Monaco, Monaco, 98000
    • CHPG
    • Contact: Isabelle ORTHOLAN; Phone Number: +37797989819; Email: isabelle.rouquette-vincenti@chpg.mc
    • Contact: Nicolas RIJO; Phone Number: +37797988445; Email: nicolas.rijo@chpg.mc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo supplementation; Placebo supplementation before surgery for inguinal hernia under general anaesthesia
Experimental: L-Tyrosine	Dietary supplement: L-tyrosine supplementation; L-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of anxiety status	Anxiety score measured using Y-A STAI	between the day before surgery and thes day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other stress markers variation	anxiety visual analogue scale (from 0 to 10, 10 is worst)	the day before surgery
Other stress markers variation	anxiety visual analogue scale (from 0 to 10, 10 is worst)	the day after surgery
Other stress markers variation	heart blood pressure (Systolic and diastolic)	the day before surgery
Other stress markers variation	heart blood pressure (Systolic and diastolic)	the day after surgery
Other stress markers variation	cortisol dosage	the day before surgery
Other stress markers variation	cortisol dosage	the day after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: L-Tyrosine supplementation; Perioperative stress
• Other Study ID Numbers: 17-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not scheduled

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No