Clinical trial NCT02324478: Exploration of Autonomic Nervous System by Photoplethysmography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervention Affecting Autonomic Nervous System
Keywords: autonomic nervous system
heart rate variability
laparoscopic surgery
general anesthesia
photoplethysmography
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults scheduled for elective laparoscopic cholecystectomy under general anaesthesia

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.


Eligibility criteria: 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

Primary outcomes:
measure: autonomic nervous system activity during laparoscopic cholecystectomy (measured by pulse-photoplethysmography and heart rate variability analysis)
timeFrame: 120 min
Secondary outcomes:
measure: agreement of photoplethysmography and heart rate variability
timeFrame: 120 min
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Luigi Sacco Hospital
Study officials:
References:
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