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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05782829

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress	Dietary Supplement: L-tyrosine supplementation Dietary Supplement: Placebo supplementation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, monocentric, double-blind randomized studyprospective, monocentric, double-blind randomized study

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: L-Tyrosine

Dietary Supplement: L-tyrosine supplementation

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

Placebo Comparator: Placebo

Dietary Supplement: Placebo supplementation

Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Outcome Measures

Primary Outcome Measures

Variation of anxiety status [between the day before surgery and thes day after surgery]
Anxiety score measured using Y-A STAI

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHPG	Monaco		Monaco	98000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT05782829

Other Study ID Numbers:

17-16

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Nice

L-Tyrosine supplementation

Perioperative stress

Study Results

No Results Posted as of Mar 24, 2023