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CompletedNCT02137057Updated Jun 15, 2015

The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients

An observational study in Heart Rate Variability, Diabetes and Spinal Anesthesia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-06-15.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Rate Variability
  • Diabetes
  • Spinal Anesthesia

Keywords

  • Heart Rate Variability
  • spinal anesthesia
  • DM
  • cardiac autonomic dysfunction
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients undergoing lower limb surgery with spinal anesthesia

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • severe coagulopathy, short height, arrhythmia patients, patients taken medication which could affect autonomic nervus system (bata- blocker or alpha-blocker)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • control ( patients without diabetes)

    patients without diabetes

  • DM ( patients with diabetes)

    patients with diabetes

06

What researchers measure

Primary outcomes

  1. Change of Heart rate variability during spinal anesthesia : total power, power of LF and HF, and LF/HF ratio

    Time frame: 10 min before spinal anesthesia (T0: Baseline ) 10 min (T1), 20 min (T2) and 30 min (T3) after spinal injection

07

Study locations

1 site
  • Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
08

References and documents

Publications

  • Lee SH, Lee DH, Ha DH, Oh YJ. Dynamics of heart rate variability in patients with type 2 diabetes mellitus during spinal anaesthesia: prospective observational study. BMC Anesthesiol. 2015 Oct 8;15:141. doi: 10.1186/s12871-015-0125-6. PubMed 26450424 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02137057
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
May 13, 2014
Start date
May 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jun 15, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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