Answering the following questions:1. Are simple autonomic function tests using continuous blood pressure measurements useful to diagnose CAN at the preoperative screening? a. Are simple autonomic function tests using continuous blood pressure…
ID
Source
Brief title
Condition
- Other condition
- Diabetic complications
Synonym
Health condition
algehele anesthesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Consistency in the results of the autonomic function tests at the outpatient
preoperative screening clinic and the official autonomic function test
laboratory.
* The correlation between CAN and intra- and postoperative hemodynamic- and
autonomic instability
Secondary outcome
* The prevalence of CAN in patients with diabetes at the preoperative
outpatient screening clinic diagnosed by analysis of patient files.
* Demographic patient variables: age, sex, weight, length, comorbidities.
Background summary
A serious complication of diabetes mellitus is cardiovascular autonomic
neuropathy (CAN), which is associated with disturbed regulation of blood
pressure, heart rate and coronary blood flow. CAN may be a perioperative risk
factor for myocardial infarctions but is difficult to diagnose. Furthermore,
preoperative assessment of cardiac risk remains challenging because reliable
and objective clinical parameters are currently lacking. We therefore aim to
define preoperative parameters which predict intraoperative and postoperative
risks.
Study objective
Answering the following questions:
1. Are simple autonomic function tests using continuous blood pressure
measurements useful to diagnose CAN at the preoperative screening?
a. Are simple autonomic function tests using continuous blood pressure
measurements at the preoperative screening valid to diagnose CAN and consistent
over time?
b. Are preoperative symptoms of CAN as measured in the preoperative screening
outpatient clinic related to peri-operative hemodynamic- and autonomic
instability?
c. What is the prevalence of patients diagnosed with CAN in diabetic patients,
who visited the preoperative outpatient screening clinic?
Study design
Open, prospective, clinical study with non-invasive measurements
Study burden and risks
In general, the burden and risks associated with the present study are minimal
due to its non-invasive character. The non-invasive autonomic neuropathy
measurements, which play a central role in this investigation, will be
performed preoperative and postoperative.
We will perform the following (cardiovascular reflex) tests:
* Classical Ewing tests (Parasympathetic function: heart rate response to deep
breathing, Valsalva ratio, heart rate changes during standing. Sympathetic
function: sustained handgrip test, systolic blood pressure response to standing)
* Measures of heart rate variability (HRV)
* Determination of Qtc intervals
The tests will only be performed when patients are comfortable with this tests
which are not related to any kind of discomfort. The remaining part of the
study will be performed by research in the status or anesthetic chart of the
participants. In total, the burden associated with the present study is
considered as minimal. There are no benefits associated with participation.
De Boelelaan 1117
1081 HV
Nederland
De Boelelaan 1117
1081 HV
Nederland
Listed location countries
Age
Inclusion criteria
* Diabetes mellitus, type II
* Age between 40*75 years
* Scheduled for surgery
* Informed consent
Exclusion criteria
* Known/documented cardiac disease
* Use of medication for hypertension
* Abnormal ECG or echocardiogram
* Peripheral vascular disease
* Renal disease requiring hemo- or peritoneal dialysis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26318.029.08 |