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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03613961
Other study ID # VGHTPE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 25, 2017
Est. completion date July 1, 2018

Study information

Verified date January 2020
Source National Central University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration.


Description:

Because the ANS, especially the sympathetic nervous system, plays a major role in regulating cardiovascular homeostasis, knowledge of how anesthetic agents modify sympathetic activity is important for understanding subsequent cardiovascular responses.

Spectral analysis of heart rate variability (HRV) is a promising new approach, widely used, noninvasive technique to assess the autonomic indexes of neural cardiac control and has been correlated to the integrity and balance of the sympathetic and parasympathetic activation status. The presence of low-frequency (LF) and high-frequency (HF) oscillatory rhythms in the variability of the R-R interval (RRI) is well established. To date, it is believed that LF is mediated by the parasympathetic and sympathetic systems, whereas HF is mediated primarily by the parasympathetic system. There has been a lot of methodological analysis developed to evaluate the ANS function during anesthesia. In this study, Continuous Wavelet Transform (CWT), believed as a reliable and robust method to access cardiorespiratory dynamics of the ANS due to its adaptability and adjustability between spectral and temporal scale using a window of variable width, was used as a method for analyzing dynamic cardiovascular signals during anesthesia.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- The subjects were selected from patients scheduled for surgery under general anesthesia.

Exclusion Criteria:

- recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function.

Study Design


Related Conditions & MeSH terms

  • Autonomic Nervous System Imbalance

Intervention

Drug:
Anesthetics
The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration. We will observe the relationship of anesthetics and HRV dynamics.

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei R.o.c

Sponsors (1)

Lead Sponsor Collaborator
National Central University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary HRV dynamics Evaluate the changes in heart rate variability at different propofol concentration 2 minutes
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