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

Sponsor
Erzincan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03869775
Collaborator
(none)
240
Enrollment
1
Location
36
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: perfusion index monitor
  • Diagnostic Test: ewing test

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 Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study Relationship Between Perfusion Index Changes and Intraoperative Complications in Cardiovascular Autonom Neuropathia Type-2 DM Patients With Spinal Anesthesia
Actual Study Start Date :
Dec 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Perfusion index change [Day 1]

    Perfusion index change in spinal anesthesia related cardiovascular autonom neuropatia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erzincanu Erzincan Merkez Turkey 24050

Sponsors and Collaborators

  • Erzincan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
faruk subasi, Asistant Doctor, Erzincan University
ClinicalTrials.gov Identifier:
NCT03869775
Other Study ID Numbers:
  • ErzincanU
First Posted:
Mar 11, 2019
Last Update Posted:
Mar 12, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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

Study Results

No Results Posted as of Mar 12, 2019