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.
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Between group difference in hemodynamic parameters and cerebral perfusion
parameters.
Secondary outcome
Determine the relationship between autonomic function tests and clinical
outcome during 30-postoperative days (observational). Outcome measures include
frequency of all adverse and serious adverse events.
Background summary
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.
Study 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.
Observations:
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.
2. INTRA-operative: we repeat the 3 minute paced breathing test and the
CO2-reactivity test.
3. POST-operative: file revision and phone call to the research patient to
detect complications 30 days postoperatively.
Study burden and risks
The study has no additional risks or benefits for the individual patient. All
measurement methods are non-invasive and can be performed on a regular ward.
All physiological tests are designed to test counterregulatory (homeostatic)
reactions to stimuli within the physiological range. Therefore, we deem it
appropriate not to give a financial compensation for participation in the
study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Willing and able to give written informed consent, scheduled for elective, non-cardiothoracic surgery under general anesthesia and age 18 years and above
Exclusion criteria
Day case surgery, laparoscopic procedure, DM type 1, Parkinson*s disease, uncontrolled cardiac arrhythmia, Pure autonomic failure (formerly called idiopathic orthostatic hypotension), Multiple system atrophy with autonomic failure (formerly called Shy-Drager syndrome), Addison*s disease and hypopituitarism, pheochromocytoma, peripheral autonomic neuropathy (e.g., amyloid neuropathy, idiopathic autonomic neuropathy), known cardiomyopathy, extreme left ventricle hypertrophy or ejection fraction < 30%, proven or suspected allergy for any of the medication used during induction of anaesthesia, malignant hyperthermia, unability to record transcranial doppler ultrasound due to anatomical variance.
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 | NL56806.018.16 |