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Exploration of Autonomic Nervous System by Photoplethysmography

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02324478
Enrollment
52
Registered
2014-12-24
Start date
2015-03-31
Completion date
2015-06-30
Last updated
2015-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervention Affecting Autonomic Nervous System

Keywords

autonomic nervous system, heart rate variability, laparoscopic surgery, general anesthesia, photoplethysmography

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.

Interventions

PROCEDUREautonomic nervous system analysis

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.

Sponsors

ASST Fatebenefratelli Sacco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
autonomic nervous system activity during laparoscopic cholecystectomy (measured by pulse-photoplethysmography and heart rate variability analysis)120 minassessment of autonomic nervous system activity measured by pulse-photoplethysmography and heart rate variability analysis

Secondary

MeasureTime frameDescription
agreement of photoplethysmography and heart rate variability120 minassessment of agreement between pulse-photoplethysmography and heart rate variability as a measure of autonomic nervous system activity

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026