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

Stress Clinical Trial

— SPOT  

Official title:

Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05782829
• Other study ID #: 17-16
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: April 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Isabelle ROUQUETTE-VINCENTI, MD, PhD
• Phone: +377 97 98 98 19
• Email: isabelle.rouquette-vincenti[@]chpg.mc
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Dietary Supplement:
• L-tyrosine supplementation
L-Tyrosine supplementation before surgery for inguinal hernia under general anaesthesia
• Placebo supplementation
Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Locations

Country	Name	City	State
Monaco	CHPG	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of anxiety status	Anxiety score measured using Y-A STAI	between the day before surgery and thes day after surgery
Secondary	Other stress markers variation	anxiety visual analogue scale (from 0 to 10, 10 is worst)	the day before surgery
Secondary	Other stress markers variation	anxiety visual analogue scale (from 0 to 10, 10 is worst)	the day after surgery
Secondary	Other stress markers variation	heart blood pressure (Systolic and diastolic)	the day before surgery
Secondary	Other stress markers variation	heart blood pressure (Systolic and diastolic)	the day after surgery
Secondary	Other stress markers variation	cortisol dosage	the day before surgery
Secondary	Other stress markers variation	cortisol dosage	the day after surgery