Diabetes Mellitus, Type 2 Clinical Trial
Official title:
QUANtification of Cardiovascular Autonomic Neuropathy (CAN) and the Effects of Anaesthesia on Haemodynamics and Cerebral Perfusion
Rationale: Complications of chronic hyperglycaemia associated with Diabetes Mellitus type 2
(DM2) include macro- and microvascular angiopathy. Cerebral Autoregulation (CA), the
capability of the brain to maintain constant cerebral blood flow (CBF) despite changes in
blood pressure, is impaired early in DM2 implicating that CBF becomes dependent on blood
pressure. In addition, 20-60% of all patients with DM2 suffers from cardiovascular autonomic
neuropathy (CAN) resulting in more unstable blood pressure regulation. In patients without
DM2 or CAN, induction of anaesthesia results in slightly decreased blood pressure, but
cerebral perfusion is maintained through CA. In contrast, patients with DM2 and CAN may
display greater reductions in blood pressure and cerebral perfusion may become jeopardized
due to impaired CA. This could be an explanation for the increased incidence of stroke in
patients with DM2.
Objective:
1. To study whether peri-operative haemodynamics fluctuate more in patients with DM2 and
CAN.
2. To study whether CAN further worsens cerebral perfusion in addition to impaired CA.
Study design: Prospective, observational cohort trial. Study population: A total of 45
patients, 30 with DM2 and 15 healthy controls scheduled for elective, non-cardiothoracic
surgery under general anesthesia and age 18 years and above will be included in the study.
After inclusion, DM2-patients will be categorized in two groups (both 15 patients): patients
with and patients without CAN. Given the prevalence of 20-60% CAN, we plan to screen at most
100 patients and include 15 patients in each study group.
Intervention (if applicable):
1. PRE-operative: chart review, short physical examination, autonomic function tests to
determine the presence of CAN. These tests are simple physiological tests that can be
performed on a regular ward and involve a Vasalva manoeuvre, 3 minute paced breathing
with a frequency of 6·min-1 and tests for orthostatic hypotension. Also, we test the
sensitivity of the cerebral vasculature to CO2 by measuring during one-minute
hyperventilation and one minute CO2-rebreathing. Continuous blood pressure monitoring
will be obtained using ccNexfin, a non-invasive monitor that comprises a single
inflatable finger cuff. Cerebral perfusion will be assessed non-invasively using
transcranial Doppler attached with a headband to the temporal skin area and
(non-invasive) measurement of cerebral oxygenation using near-infrared spectroscopy
(NIRS).
2. INTRA-operative: we repeat the 3 minute paced breathing test and the CO2-reactivity
test.
Main study parameters/endpoints: Between group difference in haemodynamic parameters and
cerebral perfusion parameters.
n/a
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