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

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137057
• Other study ID #: 4-2014-0167
• 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

• Diabetes
• Heart Rate Variability
• Spinal Anesthesia

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