Perfusion Index Changes in Cardiovascular Autonom Neuropathia Type-2 Dm Whit Spinal Anesthesia (PI)

March 10, 2019 updated by: faruk subasi, Erzincan University

Observational Study Relationship Between Perfusion Index Changes and Intraoperative Complications in Cardiovascular Autonom Neuropathia Type-2 DM Patients With Spinal Anesthesia

Cardiovascular autonomic neuropathy in diabetic patients, hypertension, sympathovagal imbalance, orthostatic hypotension, painless myocardial infarction, ischemia, left ventricular dysfunction, cardiac sympathetic and parasympathetic innervation disturbances, qt interval prolongation and sudden deaths observed. The purpose of this study is to evaluate the relationship between cardiovascular autonomic neuropathy and perfusion index in spinal anesthesia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular autonomic neuropathy in diabetic patients, hypertension, sympathovagal imbalance, orthostatic hypotension, painless myocardial infarction, ischemia, left ventricular dysfunction, cardiac sympathetic and parasympathetic innervation disturbances, qt interval prolongation and sudden deaths observed. The purpose of this study is to evaluate the relationship between cardiovascular autonomic neuropathy and perfusion index in spinal anesthesia

Study Type

Observational

Enrollment (Anticipated)

240

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients over 18 years old

Description

Inclusion Criteria:

  • the patient will be operated with spinal anesthesia
  • over 18 years
  • no additional disease and only DM

Exclusion Criteria:

  • patients with additional disease
  • patients under 18 years of age
  • patients contraindicated in spinal anesthesia

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
Intervention / Treatment
control group
no additional disease
Device: perfusion index monitor
perfusion index measured in patients undergoing spinal anesthesia with non-invasive perfusion index monitor
working group-1
additional disease only DM and no cardıovascular autonomous neuropathıa
Device: perfusion index monitor
perfusion index measured in patients undergoing spinal anesthesia with non-invasive perfusion index monitor
Diagnostic test: ewing test
ewing tests will be applied to diabetic patients undergoing spinal anesthesia for cardıovascular autonomous neuropathıa diagnosis
working group-2
additional disease only DM and pozitif cardıovascular autonomous neuropathıa
Device: perfusion index monitor
perfusion index measured in patients undergoing spinal anesthesia with non-invasive perfusion index monitor
Diagnostic test: ewing test
ewing tests will be applied to diabetic patients undergoing spinal anesthesia for cardıovascular autonomous neuropathıa diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfusion index change
Time Frame: Day 1
Perfusion index change in spinal anesthesia related cardiovascular autonom neuropatia
Day 1

Collaborators and Investigators

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

Sponsor

Erzincan University

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 (ACTUAL)

December 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (ACTUAL)

March 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 10, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ErzincanU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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.

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