Lumbar Disc Disease, Lumbar Disc Herniation, Lumbar Fracture, Lumbar Spinal Stenosis
Conditions
Keywords
transcranial doppler ultrasonography, high blood pressure, cerebral perfusion, prone position
Brief summary
High blood pressure is a serious and common health problem. This disease affects 1 billion people all over the world and responsible for 7,1 million deaths. Trials involving more than 1 million people state that stroke incidence rises as blood pressure rises. The effects of high blood pressure on cerebral perfusion is not well realized. Intraoperative blood pressure management of patients with high blood pressure is not well known. And it is still not clear how autoregulation of cerebral perfusion is affected by high blood pressure. Systemic arterial pressure changes have little effect on cerebral perfusion. This is regulated by changes of precapillary resistance. When systemic arterial blood pressure drops, it is regulated by vasodilatation of arteriolar smooth muscles. And when systemic blood pressure rises, it is regulated by vasoconstriction of arterioles. Cerebral perfusion is well preserved between 50-125 mmHg changes of mean arterial blood pressure (MAP). Patients with high blood pressure have higher ranges. Patients with chronic high blood pressure can better tolerate higher blood pressures. But even physiologic drops of systemic blood pressure can cause ischemia. Anesthetic drugs have variable effects on cerebral blood flow and physiology. The drugs used with anesthetic drugs, the noxious stimulus of surgery, intracranial compliance, blood pressure, and carbon dioxide pressure can all alter and complicate these effects. Anesthetic drugs must be selected carefully in patients with high blood pressure. It is still investigated whether, management of blood pressure under anesthesia, should be individualized. For patients with high blood pressure, some neuromonitorization technics have been evaluated to prevent neurologic complications under anesthesia. But there is not a technic, which is considered as a gold standard. Cerebral blood pressure has been studied by, nitrous oxide method, krypton uptake method, and xenon injection methods previously. Near-infrared spectroscopy (NIRS) is the best monitorization technic of intracranial pressure (ICP), cerebral blood flow (CBF), and cerebral metabolism. But it can not be applied to all patients. Recently, it is possible to measure blood flow of cerebrum with transcranial Doppler ultrasound in anesthesia practice. In this trial, the investigators aim to evaluate cerebral perfusion of hypertensive patients with transcranial Doppler during lumbar disc surgery to optimize the blood pressure under anesthesia. To best of our knowledge, there is no trial evaluating cerebral perfusion of hypertensive patients with transcranial Doppler ultrasound.
Detailed description
In this trial, the investigators aim to evaluate the cerebral perfusion of patients with transcranial doppler ultrasound (TCD) and near-infrared spectroscopy (NIRS) during lumbar disc surgery. The investigators will divide participants into three groups according to their blood pressure history after preoperative evaluation of the participants. The investigators will enroll normotensive participants in group 1(control group). Participants with diagnosis of high blood pressure will be enrolled to group 2. In the third group, participants who don't have any diagnosis of high blood pressure, but actual blood pressure is higher than the physiological levels at the preoperative evaluation will be enrolled to group 3. First measurements of TCD and NIRS, will be performed at preoperative period. Second measurements will be obtained after anesthesia induction. Third measurement will be performed after prone position. Forth measurement will be taken after 1 hour of surgical incision. The last measurement will be performed at the postoperative period. During all these measurements, blood gas samples, invasive arterial blood pressures, pulse variation index (PVI), electrocardiography (ECG), peripheral oxygen saturation (SpO2), peak pressure of airway and end-tidal carbon dioxide (EtCO2) levels will also be recorded. All participants will be evaluated for their cognitive functions with mini-mental and confusion assessment method (cam) tests at the preoperative and postoperative periods.
Interventions
PROCEDUREnormotensive patients
patients who do not have high blood pressure diagnosis and actual blood pressure is within the normal range
PROCEDUREpatients with hypertension diagnosis
Patients who have high blood pressure diagnosis
PROCEDUREpatients who do not know they are hypertensive but actual blood pressure is high
patients with preoperative high blood pressure, who do not know they are hypertensive
Sponsors
Akdeniz University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients with mental retardation, with brain tumor, head trauma, cerebral aneurysm, cerebrovascular accident, dementia, psychiatric disease, and carotid stenosis were excluded from the study.
Intervention model description
Patients, aged between 18 and 85, who were scheduled for lumbar surgery under general anesthesia by neurosurgery department and were classified as Class I, II, and III according to the ASA (American Association of Anesthesiologists) classification, were included in the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of lumbar stenosis Clinical diagnosis of lumbar fracture Clinical diagnosis of lumbar mass -
Exclusion criteria
Patients who had an intracranial incident Patients with anesthetic risk classification higher than American Society of Anesthesiology (ASA) 3 Carotid atherosclerosis \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean cerebral perfusion pressure of hypertensive patients under anesthesia | time from the preoperative period of the surgery until the postoperative 24th hour of the surgery | Mean cerebral perfusion pressure will be measured by transcranial doppler ultrasonography under anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of transcranial doppler and near-infrared spectroscopy for determining of cerebral perfusion | time from the preoperative period of the surgery until the postoperative 24th hour of the surgery | Transcranial doppler and near-infrared spectroscopy measurements will be compared by neurocognitive tests after the surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determination of changes of the cerebral perfusion in patients with actual high blood pressure who has not been diagnosed for hypertension before. | time from the preoperative period of the surgery until the postoperative 24th hour of the surgery | Mean cerebral arterial pressure of patients with actual high blood pressure but without hypertension diagnosis will be measured by transcranial doppler ultrasonography |
Countries
Turkey (Türkiye)
Outcome results
None listed