The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure

Lumbar Spinal Stenosis Clinical Trial

Official title:

The Effects of Anesthesia on Cerebral Perfusion Identified by Transcranial Doppler During Lumbar Surgery in Prone Position in Patients With High Blood Pressure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587401
• Other study ID #: AkdenizU-438
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 2, 2021

Study information

• Verified date: September 2020
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

-

Related Conditions & MeSH terms

• Hypertension
• Intervertebral Disc Displacement
• Lumbar Disc Disease
• Lumbar Disc Herniation
• Lumbar Fracture
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• normotensive patients
patients who do not have high blood pressure diagnosis and actual blood pressure is within the normal range
• patients with hypertension diagnosis
Patients who have high blood pressure diagnosis
• patients 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

Locations

Country	Name	City	State
Turkey	Akdeniz University Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determination of changes of the cerebral perfusion in patients with actual high blood pressure who has not been diagnosed for hypertension before.	Mean cerebral arterial pressure of patients with actual high blood pressure but without hypertension diagnosis will be measured by transcranial doppler ultrasonography	time from the preoperative period of the surgery until the postoperative 24th hour of the surgery
Primary	Mean cerebral perfusion pressure of hypertensive patients under anesthesia	Mean cerebral perfusion pressure will be measured by transcranial doppler ultrasonography under anesthesia	time from the preoperative period of the surgery until the postoperative 24th hour of the surgery
Secondary	Comparison of transcranial doppler and near-infrared spectroscopy for determining of cerebral perfusion	Transcranial doppler and near-infrared spectroscopy measurements will be compared by neurocognitive tests after the surgery	time from the preoperative period of the surgery until the postoperative 24th hour of the surgery