Exploration of Autonomic Nervous System by Photoplethysmography
- Conditions
- Intervention Affecting Autonomic Nervous System
- Registration Number
- NCT02324478
- Lead Sponsor
- ASST Fatebenefratelli Sacco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- aged between 18 and 50 years
- American Society of Anaesthesiologists status I and II
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Luigi Sacco Hospital
🇮🇹Milan, Italy