Anesthesia; Adverse EffectPINCT03869775
Perfusion Index Changes in Cardiovascular Autonom Neuropathia Type-2 Dm Whit Spinal Anesthesia
An observational study of Anesthesia; Adverse Effect, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia; Adverse Effect
- What is being tested?
- perfusion index monitor and ewing test
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2017to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients over 18 years old
Who may be able to join
- the patient will be operated with spinal anesthesia
- over 18 years
- no additional disease and only DM
Who cannot join
- patients with additional disease
- patients under 18 years of age
- patients contraindicated in spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzincanu
Erzincan, Merkez, 24050
FARUK SUBAŞI, 5414247924, dr.faruksubasi@gmail.com
About this study
Official title: 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
Read the 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
- Conditions
- Anesthesia; Adverse Effect
- Being tested
- perfusion index monitor, ewing test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion index monitorDevice
perfusion index measured in patients undergoing spinal anesthesia with non-invasive perfusion index monitor
ewing testDiagnostic test
ewing tests will be applied to diabetic patients undergoing spinal anesthesia for cardıovascular autonomous neuropathıa diagnosis
| Study group | Role | What they receive |
|---|---|---|
| control group | no additional disease Receives: Device: perfusion index monitor | |
| working group-1 | additional disease only DM and no cardıovascular autonomous neuropathıa Receives: Device: perfusion index monitor; Diagnostic Test: ewing test | |
| working group-2 | additional disease only DM and pozitif cardıovascular autonomous neuropathıa Receives: Device: perfusion index monitor; Diagnostic Test: ewing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index change
Perfusion index change in spinal anesthesia related cardiovascular autonom neuropatia
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Dec 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, faruk subasi, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869775
- Sponsor's protocol ID
- ErzincanU
- Acronym
- PI
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Relationship Between Perfusion Index Changes and Intraoperative Complications in Cardiovascular Autonom Neuropathia Type-2 DM Patients With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03869775
- Acronym / sponsor ID
- PI / ErzincanU
- Conditions
- Anesthesia; Adverse Effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Device: perfusion index monitorno additional disease |
| working group-1 | – | Device: perfusion index monitor, Diagnostic Test: ewing testadditional disease only DM and no cardıovascular autonomous neuropathıa |
| working group-2 | – | Device: perfusion index monitor, Diagnostic Test: ewing testadditional disease only DM and pozitif cardıovascular autonomous neuropathıa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients over 18 years old
Key inclusion criteria (3 listed)
- the patient will be operated with spinal anesthesia
- over 18 years
- no additional disease and only DM
Key exclusion criteria (3 listed)
- patients with additional disease
- patients under 18 years of age
- patients contraindicated in spinal anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perfusion index monitorperfusion index measured in patients undergoing spinal anesthesia with non-invasive perfusion index monitor | Device | control group, working group-1, working group-2 |
| ewing testewing tests will be applied to diabetic patients undergoing spinal anesthesia for cardıovascular autonomous neuropathıa diagnosis | Diagnostic test | working group-1, working group-2 |
Primary outcome
Perfusion index change
Time frame: Day 1
Perfusion index change in spinal anesthesia related cardiovascular autonom neuropatia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Adverse Effect, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FARUK SUBAŞI (5414247924, dr.faruksubasi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion index change (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.