QUANtification of Cardiovascular Autonomic Neuropathy (CAN) and the Effects of Anaesthesia on Haemodynamics and Cerebral Perfusion (QUANCAN)
Anesthesia, Diabetes Mellitus, Type 2
About this trial
This is an interventional diagnostic trial for Anesthesia
Eligibility Criteria
Inclusion criteria:
- Willing and able to give written informed consent
- Scheduled for elective, non-cardiothoracic surgery under general anesthesia
- 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.
Sites / Locations
- Academic Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Non-diabetic patients
Diabetic patients with cardiovascular autonomic neuropathy
Diabetic patients without cardiovascular autonomic neuropathy
Study interventions include a medical history and short physical examination as well as autonomic function tests and cerebral autoregulation tests on the day before surgery. In addition we determine CO2 sensitivity of the cerebral vasculature by three minutes hyperventilation and three minutes CO2 rebreathing. Perioperatively, continuous measurement of heart rate, blood pressure, stroke volume and cardiac output is aquired using the ccNexfin monitor, a non-invasive device using a single finger cuff. Continuous monitoring of cerebral perfusion parameters using transcranial Doppler ultrasound (TCD) of the middle cerebral artery (MCA) and cerebral oxygenation using near-infrared-spectroscopy (NIRS) will be obtained. BRS and condition of CA will be determined preoperatively during autonomic function testing (see below) and 30 minutes after induction of anaesthesia.
Study interventions include a medical history and short physical examination as well as autonomic function tests and cerebral autoregulation tests on the day before surgery. In addition we determine CO2 sensitivity of the cerebral vasculature by three minutes hyperventilation and three minutes CO2 rebreathing. Perioperatively, continuous measurement of heart rate, blood pressure, stroke volume and cardiac output is aquired using the ccNexfin monitor, a non-invasive device using a single finger cuff. Continuous monitoring of cerebral perfusion parameters using transcranial Doppler ultrasound (TCD) of the middle cerebral artery (MCA) and cerebral oxygenation using near-infrared-spectroscopy (NIRS) will be obtained. BRS and condition of CA will be determined preoperatively during autonomic function testing (see below) and 30 minutes after induction of anaesthesia.
Study interventions include a medical history and short physical examination as well as autonomic function tests and cerebral autoregulation tests on the day before surgery. In addition we determine CO2 sensitivity of the cerebral vasculature by three minutes hyperventilation and three minutes CO2 rebreathing. Perioperatively, continuous measurement of heart rate, blood pressure, stroke volume and cardiac output is aquired using the ccNexfin monitor, a non-invasive device using a single finger cuff. Continuous monitoring of cerebral perfusion parameters using transcranial Doppler ultrasound (TCD) of the middle cerebral artery (MCA) and cerebral oxygenation using near-infrared-spectroscopy (NIRS) will be obtained. BRS and condition of CA will be determined preoperatively during autonomic function testing (see below) and 30 minutes after induction of anaesthesia.