Exploration of Autonomic Nervous System by Photoplethysmography

Sponsor

ASST Fatebenefratelli Sacco (Other)

Overall Status

Completed

CT.gov ID

NCT02324478

Collaborator

(none)

Enrollment

Location

Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The autonomic nervous system state (ANSS) and the autonomic nervous system state index (ANSSi) - two indices derived from the pulse photo-plethysmography analysis - have been recently advocated as a measure of sympathetic activity in the anesthetized patients, but their validity has not been yet demonstrated. We will conduct a study aiming to assess if ANSS and ANSSi reflect autonomic nervous system modulation on cardiovascular system in healthy humans under general anaesthesia.

Condition or Disease	Intervention/Treatment	Phase
Intervention Affecting Autonomic Nervous System	Procedure: autonomic nervous system analysis

Study Design

Study Type:

Observational

Anticipated Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Outcome Measures

Primary Outcome Measures

autonomic nervous system activity during laparoscopic cholecystectomy (measured by pulse-photoplethysmography and heart rate variability analysis) [120 min]
assessment of autonomic nervous system activity measured by pulse-photoplethysmography and heart rate variability analysis

Secondary Outcome Measures

agreement of photoplethysmography and heart rate variability [120 min]
assessment of agreement between pulse-photoplethysmography and heart rate variability as a measure of autonomic nervous system activity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

aged between 18 and 50 years
American Society of Anaesthesiologists status I and II

Exclusion Criteria:

hypertension requiring pharmacological treatment or chronic cardiovascular disease
arrhythmic cardiac disease (atrial fibrillation, atrial flutter, ectopic beats >5% of normal sinus beats)
history of alcohol or drug abuse
obesity (BMI>30)
diabetes or other endocrine pathology (thyroidal or adrenal)
peripheral neuropathy or any kind of chronic neurological disease