What is the incidence of a blood pressure decrease of more than 20% after spinal anesthesia in patients with diabetes mellitus type II in comparison with non-diabetics?
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Preoperative heart rate variability and arterial blood pressure changes during
spinal anesthesia in patients with and without diabetes mellitus.
Secondary outcome
Autonomic function, heart rate and blood pressure response as measured by heart
rate variability, forced breathing and the cold pressure test
Background summary
Spinal anesthesia is a form of regional anesthesia involving injection of a
local anesthetic into the subarachnoid space. Spinal anesthesia causes somewhat
similar effects as intravenous *1- and *-adrenergic blockers, including
decreased heart rate and arterial pressure. Although these hemodynamic changes
may occur more frequently in patients with diabetes mellitus II due to
cardiovascular and autonomic nervous system disorders, there are only limited
data available with respect to the specific effects of diabetes on blood
pressure control during spinal anesthesia. In the present study we aim to
evaluate whether patients with diabetes develop a relatively stronger blood
pressure drop after spinal anesthesia in comparison with non-diabetics. In
particular, we will investigate whether preoperative information about heart
rate variability may be used as predictor for intraoperative blood pressure
drops after spinal anesthesia.
Study objective
What is the incidence of a blood pressure decrease of more than 20% after
spinal anesthesia in patients with diabetes mellitus type II in comparison with
non-diabetics?
Study design
Open, prospective observational multicenter study
Study burden and risks
Non-invasive beat-to-beat blood pressure monitoring: All included subjects
receive a finger cuff to measure arterial blood pressure. This cuff may in some
cases lead to local cyanosis in the finger, but this is not experienced as
discomfortable. Assessment of autonomic function: All included subjects undergo
non-invasive cardiovascular reflex tests in the hour before surgery that will
not add up to patient discomfort.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
Age between 18*85 years
Elective surgery with spinal anesthesia
Informed consent
Exclusion criteria
Refusal of spinal anesthesia
Caesarean section
Pregnancy
Peripheral vascular disease
Renal disease requiring hemodialysis or peritoneal dialysis
Diabetes mellitus I
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 | NL33491.029.10 |