Exploration of Autonomic Nervous System by Photoplethysmography

Intervention Affecting Autonomic Nervous System Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324478
• Other study ID #: ANSSi_2
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: June 23, 2015
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Ospedale L. Sacco – Polo Universitario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Etichs Comittee: Milan, Italy
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intervention Affecting Autonomic Nervous System

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	Luigi Sacco Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale L. Sacco – Polo Universitario

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Myles PS, Cui J. Using the Bland-Altman method to measure agreement with repeated measures. Br J Anaesth. 2007 Sep;99(3):309-11. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	120 min	No
Secondary	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	120 min	No