Clinical Trials Directory

Trials / Completed

CompletedNCT04275375

Autonomic Modulation After Spinal Anesthesia With Depth of Anesthesia and Vital Signs.

Department of Anaesthesiology, Taipei Veterans General Hospita, Taipei, Taiwan

Status
Completed
Phase
Study type
Observational
Enrollment
46 (actual)
Sponsor
National Central University · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Spinal anaesthesia has the advantage that produced nerve block by the injection of local anaesthetic into cerebrospinal fluid (CSF). However, the greatest challenge in spinal anaesthesia is to control the spread of local anaesthetic through the CSF to provide a block which is adequate for the proposed surgery without unnecessary extensive spread, and increased risk of complications.

Detailed description

The activity of the autonomic nervous system is of fundamental importance in the regulation of vital bodily functions. Unbalance of autonomic nerve system results in considerably disordered vital function. Clinically, this is of great significance, because if an anesthetic agent produces cause the sympathetic system to block, the effects can be serious in individual cases, particularly on the cardiovascular system. If complications are to be avoided, it is essential to assess the degree of block correctly. Clinical monitoring has a variety of applications, a particularly useful one being measurement of the sympathetic system during regional anesthesia, for which quantification of the blocking effect is a clinical necessity and the degree of block needs to be ascertained without delay. The autonomic nervous system (ANS) plays an important role in the regulation of hemodynamics during anesthesia. Analysis of beat-to-beat fluctuations of heart rate and blood pressure is a promising new approach to the clinical diagnosis and management of alterations in cardiovascular regulation. Continuous Wavelet Transform (CWT), which could overcome the limitation of the steady-state assumption in the classical spectral analysis, is believed as a reliable and robust method to access cardiorespiratory dynamics of the ANS and the investigators will applied during spinal anesthesia to evaluate the detail changes.

Conditions

Interventions

TypeNameDescription
OTHERobservation study about the autonomic response after spinal anesthesiaECG waveforms were continuously recorded using a multichannel polygraphic system (Embla N7000, Natus, Pleasanton, CA). The data were saved at a rate of 1024 Hz directly to a memory card within the device for offline analysis of heart rate variability (HRV) and PPG. All data included in the analysis were obtained from continuous artifact-free ECG recordings for analysis of the immediate effects of spinal anesthesia.

Timeline

Start date
2019-03-01
Primary completion
2019-08-16
Completion
2019-08-16
First posted
2020-02-19
Last updated
2022-07-28

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04275375. Inclusion in this directory is not an endorsement.