Heart Rate VariabilityNCT02137057
The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients
An observational study of Heart Rate Variability and Diabetes, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Heart Rate Variability, Diabetes, Spinal Anesthesia
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2014
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing lower limb surgery with spinal anesthesia
Who may be able to join
- patients undergoing lower limb surgery with spinal anesthesia (ASA class 1,2,3)
Who cannot join
- severe coagulopathy, short height, arrhythmia patients, patients taken medication which could affect autonomic nervus system (bata- blocker or alpha-blocker)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
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.
- Conditions
- Heart Rate Variability, Diabetes, Spinal Anesthesia
- Keywords
- Heart Rate Variability, spinal anesthesia, DM, cardiac autonomic dysfunction
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control ( patients without diabetes) | patients without diabetes | |
| DM ( patients with diabetes) | patients with diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Heart rate variability during spinal anesthesia : total power, power of LF and HF, and LF/HF ratio
Measured: 10 min before spinal anesthesia (T0: Baseline ) 10 min (T1), 20 min (T2) and 30 min (T3) after spinal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137057
- Sponsor's protocol ID
- 4-2014-0167
- Status last verified
- Jun 2015
- First submitted
- 11 May 2014
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26450424
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02137057
- Acronym / sponsor ID
- 4-2014-0167
- Conditions
- Heart Rate Variability, Diabetes, Spinal Anesthesia
- Keywords
- Heart Rate Variability, spinal anesthesia, DM, cardiac autonomic dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 May 2014 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control ( patients without diabetes) | – | –patients without diabetes |
| DM ( patients with diabetes) | – | –patients with diabetes |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing lower limb surgery with spinal anesthesia
Key inclusion criteria (1 listed)
- patients undergoing lower limb surgery with spinal anesthesia (ASA class 1,2,3)
Key exclusion criteria (1 listed)
- severe coagulopathy, short height, arrhythmia patients, patients taken medication which could affect autonomic nervus system (bata- blocker or alpha-blocker)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Heart rate variability during spinal anesthesia : total power, power of LF and HF, and LF/HF ratio
Time frame: 10 min before spinal anesthesia (T0: Baseline ) 10 min (T1), 20 min (T2) and 30 min (T3) after spinal injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Derived from this study: PubMed 26450424Lee 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Rate Variability and Diabetes, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jun 2015. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Heart rate variability during spinal anesthesia : total power, power of LF and HF, and LF/HF ratio (time frame: 10 min before spinal anesthesia (T0: Baseline ) 10 min (T1), 20 min (T2) and 30 min (T3) after spinal injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137057, which also lists 1 linked publication.
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 15 Jun 2015.