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

C

Centre Hospitalier Universitaire de Nice

Status

Enrolling

Conditions

Stress

Treatments

Dietary Supplement: L-tyrosine supplementation
Dietary Supplement: Placebo supplementation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups, including a placebo group

L-Tyrosine
Experimental group
Treatment:
Dietary Supplement: L-tyrosine supplementation
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo supplementation

Trial contacts and locations

1

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Central trial contact

Nicolas RIJO; Bertrand PRUNET, PU-PH

Data sourced from clinicaltrials.gov

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