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

June 12, 2015 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing lower limb surgery with spinal anesthesia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
control ( patients without diabetes)
patients without diabetes
DM ( patients with diabetes)
patients with diabetes

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 11, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4-2014-0167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe