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

ConditionStress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • L-tyrosine supplementation

    Dietary supplement

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

  • Placebo supplementation

    Dietary supplement

    Placebo supplementation before surgery for inguinal hernia under general anaesthesia

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: L-TyrosineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Variation of anxiety status

Anxiety score measured using Y-A STAI

Time frame
between the day before surgery and thes day after surgery

Secondary outcomes

1

Other stress markers variation

anxiety visual analogue scale (from 0 to 10, 10 is worst)

Time frame
the day before surgery
2

Other stress markers variation

anxiety visual analogue scale (from 0 to 10, 10 is worst)

Time frame
the day after surgery
3

Other stress markers variation

heart blood pressure (Systolic and diastolic)

Time frame
the day before surgery
4

Other stress markers variation

heart blood pressure (Systolic and diastolic)

Time frame
the day after surgery

Other outcomes

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