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Completed

NCT Number: NCT02324478

Exploration of Autonomic Nervous System by Photoplethysmography

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.

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Key information

Conditions

Intervention Affecting Autonomic Nervous System

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Luigi Sacco Hospital

Milan, 20157, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autonomic nervous system analysis

Procedure

electrocardiographic and pulse-photoplethysmographic waves of patients under general anesthesia for laparoscopic cholecystectomy will be recorded on a laptop pc for offline analysis of autonomic nervous system modulation a three main time point: 1) at baseline, before general anesthesia induction, 2) five min after tracheal tube placement, 3) five min after pneumoperitoneum insufflation.

Primary outcomes

  1. autonomic nervous system activity during laparoscopic cholecystectomy (measured by pulse-photoplethysmography and heart rate variability analysis)

    Time frame: 120 min

    assessment of autonomic nervous system activity measured by pulse-photoplethysmography and heart rate variability analysis

Secondary outcomes

  1. agreement of photoplethysmography and heart rate variability

    Time frame: 120 min

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

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2014
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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