cardiovascular autonomic neuropathy Diabetes mellitus Surgery
Conditions
Interventions
On the day before surgery, patients will be subjected to 5 non-invasive tests to assess diabetic CAN, there will be no invasive test performed for study purposes.
Sponsors
Academic medical Centre, Department of Anaesthesiology
Eligibility
Inclusion criteria
Inclusion criteria: • Willing and able to give written informed consent • (DM type 1 or type 2) • Scheduled for major gastro-intestinal- or cardiothoracic surgery • Age 18-85 years • Sinus rhythm
Exclusion criteria
Exclusion criteria: • Parkinson’s disease • 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 hypertophy21 • Ejection fraction < 30%21 • Proven or suspected allergy for any of the medication used during induction of anaesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -The prevalence of CAN in this surgical population -The relation between the stage of CAN and hemodynamic changes* * Hemodynamic changes are defined as: -Postinduction hypotension: mean arterial pressure <55 mmHg measured within first 10 minutes after start induction. -Postinduction mean arterial pressure; lowest mean blood pressure measured within first 10 minutes after start induction. -Postinduction blood pressure change: difference between highest mean arterial pressure before induction and lowest after induction before intubation. -Postinduction heart rate change: difference between minimum heart rate after induction and maximum heart rate before induction. -Maximum heart rate during tracheal intubation. -Maximum mean arterial blood pressure during tracheal intubation. -Perioperative inotropics; definition: total dose of inotropics (mcg/kg/hour) during surgery. Maximal dose during surgery (mcg/kg/hour) -Perioperative hypotension: mean arterial pressure < 55 mmHg at any time during the procedure. -Postoperative inotropics; definition: total dose (mcg/kg/hour) of inotropics after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Ejection fraction postoperative compared to preoperatively in patients undergoing cardiac surgery, (pre- and postoperative transthoracic/transesophageal ultrasound images are made for standard care). - Mean glucose during surgery, glucose increase during surgery, hyperglycaemia (>10 mmol/l) during surgery (measured for standard care). - Plasma creatinine difference before and day 0, 1 and 2 after surgery (when measured for standard care). - Length of ICU and/or in-hospital stay - Length of inotropic dependent hours after surgery - In-hospital mortality < 30 days after surgery - Duration of DM - Presence of other DM related complications o Peripheral neuropathy (assessed with the Semmes-Weinstein test and tuning fork) o Presence of micro-albuminuria (from treating physician) o Retinopathy (based on last visit to ophthalmologist) - Relation between DM related complications and stage of CAN | — |
Contacts
Public ContactJorinde Polderman
Outcome results
None listed