NCT03869775

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 6, 2019

Last Update Submit

March 10, 2019

Conditions

Anesthesia; Adverse Effect

Outcome Measures

Primary Outcomes (1)

  • Perfusion index change

    Perfusion index change in spinal anesthesia related cardiovascular autonom neuropatia

    Day 1

Study Arms (3)

control group

no additional disease

Device: perfusion index monitor

working group-1

additional disease only DM and no cardıovascular autonomous neuropathıa

Device: perfusion index monitorDiagnostic Test: ewing test

working group-2

additional disease only DM and pozitif cardıovascular autonomous neuropathıa

Device: perfusion index monitorDiagnostic Test: ewing test

Interventions

perfusion index monitorDEVICE

perfusion index measured in patients undergoing spinal anesthesia with non-invasive perfusion index monitor

control groupworking group-1working group-2
ewing testDIAGNOSTIC_TEST

ewing tests will be applied to diabetic patients undergoing spinal anesthesia for cardıovascular autonomous neuropathıa diagnosis

working group-1working group-2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients over 18 years old

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincanu

Erzincan, Merkez, 24050, Turkey (Türkiye)

RECRUITING

Central Study Contacts

FARUK SUBAŞI

CONTACT

5414247924dr.faruksubasi@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Doctor

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 11, 2019

Study Start

December 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

TU(1)