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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02137057
Other study ID # 4-2014-0167
Secondary ID
Status Completed
Phase N/A
First received May 11, 2014
Last updated June 12, 2015
Start date May 2014
Est. completion date December 2014

Study information

Verified date June 2015
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Cardiac autonomic neuropathy is a common complication of diabetes and is associated with resting tachycardia. Regional anesthesia could interrupt normal autonomic activity by central sympathetic blockade. The investigators evaluate the relation of severity of diabetes and heart rate variability, also the impact of spinal anesthesia on the change of heart rate variability.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- patients undergoing lower limb surgery with spinal anesthesia (ASA class 1,2,3)

Exclusion Criteria:

- severe coagulopathy, short height, arrhythmia patients, patients taken medication which could affect autonomic nervus system (bata- blocker or alpha-blocker)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Heart rate variability during spinal anesthesia : total power, power of LF and HF, and LF/HF ratio 10 min before spinal anesthesia (T0: Baseline ) 10 min (T1), 20 min (T2) and 30 min (T3) after spinal injection No
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