Exploration of Autonomic Nervous System by Photoplethysmography

NCT ID: NCT02324478

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Intervention Affecting Autonomic Nervous System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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autonomic 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASST Fatebenefratelli Sacco

OTHER

Sponsor Role lead

Responsible Party

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Riccardo Colombo

autonomic nervous system analysis during laparoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Luigi Sacco Hospital

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 22369767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24284309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1959222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1358002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17702826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8688262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20354006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9614745 (View on PubMed)

Other Identifiers

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ANSSi_2

Identifier Type: -

Identifier Source: org_study_id

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