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CompletedNCT02324478Updated Jun 25, 2015

Exploration of Autonomic Nervous System by Photoplethysmography

An observational study in Intervention Affecting Autonomic Nervous System, sponsored by ASST Fatebenefratelli Sacco. Completed at 1 site in Italy. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-06-25.

Sponsored by ASST Fatebenefratelli Sacco · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

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Conditions studied

  • Intervention Affecting Autonomic Nervous System

Keywords

  • autonomic nervous system
  • heart rate variability
  • laparoscopic surgery
  • general anesthesia
  • photoplethysmography
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In context

Lead sponsor

ASST Fatebenefratelli Sacco is the lead sponsor of 38 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adults scheduled for elective laparoscopic cholecystectomy under general anaesthesia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (estimated)
Patient registry
No

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.

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What researchers measure

Primary outcomes

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

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

    Time frame: 120 min

Secondary outcomes

  1. agreement of photoplethysmography and heart rate variability

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

    Time frame: 120 min

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Study locations

1 site
  • Luigi Sacco Hospital
    Milan, 20157, Italy
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References and documents

Publications

  • Hamunen K, Kontinen V, Hakala E, Talke P, Paloheimo M, Kalso E. Effect of pain on autonomic nervous system indices derived from photoplethysmography in healthy volunteers. Br J Anaesth. 2012 May;108(5):838-44. doi: 10.1093/bja/aes001. Epub 2012 Feb 26. PubMed 22369767 ↗
  • Colombo R, Raimondi F, Corona A, Rivetti I, Pagani F, Porta VD, Guzzetti S. Comparison of the Surgical Pleth Index with autonomic nervous system modulation on cardiac activity during general anaesthesia: A randomised cross-over study. Eur J Anaesthesiol. 2014 Feb;31(2):76-84. doi: 10.1097/01.EJA.0000436116.06728.b3. PubMed 24284309 ↗
  • Sly WS, Sato S, Zhu XL. Evaluation of carbonic anhydrase isozymes in disorders involving osteopetrosis and/or renal tubular acidosis. Clin Biochem. 1991 Aug;24(4):311-8. doi: 10.1016/0009-9120(91)80005-n. PubMed 1959222 ↗
  • Monk TG, Ding Y, White PF. Total intravenous anesthesia: effects of opioid versus hypnotic supplementation on autonomic responses and recovery. Anesth Analg. 1992 Nov;75(5):798-804. doi: 10.1213/00000539-199211000-00026. PubMed 1358002 ↗
  • Myles PS, Cui J. Using the Bland-Altman method to measure agreement with repeated measures. Br J Anaesth. 2007 Sep;99(3):309-11. doi: 10.1093/bja/aem214. No abstract available. PubMed 17702826 ↗
  • O'Leary E, Hubbard K, Tormey W, Cunningham AJ. Laparoscopic cholecystectomy: haemodynamic and neuroendocrine responses after pneumoperitoneum and changes in position. Br J Anaesth. 1996 May;76(5):640-4. doi: 10.1093/bja/76.5.640. PubMed 8688262 ↗
  • Paloheimo MP, Sahanne S, Uutela KH. Autonomic nervous system state: the effect of general anaesthesia and bilateral tonsillectomy after unilateral infiltration of lidocaine. Br J Anaesth. 2010 May;104(5):587-95. doi: 10.1093/bja/aeq065. Epub 2010 Mar 30. PubMed 20354006 ↗
  • Porta A, Baselli G, Caiani E, Malliani A, Lombardi F, Cerutti S. Quantifying electrocardiogram RT-RR variability interactions. Med Biol Eng Comput. 1998 Jan;36(1):27-34. doi: 10.1007/BF02522854. PubMed 9614745 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2015, a primary completion of Jun 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2014
First posted
Dec 24, 2014
Start
Mar 2015
Primary completionActual
Jun 2015
CompletionActual
Jun 2015
Last update
Jun 25, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02324478
Lead sponsor
ASST Fatebenefratelli Sacco
Responsible party
Riccardo Colombo (autonomic nervous system analysis during laparoscopy, ASST Fatebenefratelli Sacco) — Principal investigator
First posted
Dec 24, 2014
Start date
Mar 2015
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jun 25, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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