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

NCT ID: NCT02137057

Last Updated: 2015-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Rate Variability Diabetes Spinal Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control ( patients without diabetes)

patients without diabetes

No interventions assigned to this group

DM ( patients with diabetes)

patients with diabetes

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 26450424 (View on PubMed)

Other Identifiers

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4-2014-0167

Identifier Type: -

Identifier Source: org_study_id

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