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

NCT ID: NCT04587401

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-03-02

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.

Conditions

Lumbar Disc Disease; Lumbar Spinal Stenosis; Lumbar Disc Herniation; Lumbar Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

normotensive patients

Cerebral perfusion of normotensive patients who will have lumbar surgery at the prone position will be measured by transcranial doppler ultrasonography

Group Type: EXPERIMENTAL

normotensive patients

Intervention Type: PROCEDURE

patients who do not have high blood pressure diagnosis and actual blood pressure is within the normal range

patients with high blood pressure diagnosis

Cerebral perfusion of patients with high blood pressure diagnosis who will have lumbar surgery at the prone position will be measured by transcranial doppler ultrasonography

Group Type: EXPERIMENTAL

patients with hypertension diagnosis

Intervention Type: PROCEDURE

Patients who have high blood pressure diagnosis

patients who do not know they are hypertensive but actual blood pressure is high

cerebral perfusion of patients who do not have high blood pressure diagnosis but actual preoperative blood pressure is higher than normal levels will be measured by transcranial doppler ultrasonography during lumbar surgery

Group Type: EXPERIMENTAL

patients who do not know they are hypertensive but actual blood pressure is high

Intervention Type: PROCEDURE

patients with preoperative high blood pressure, who do not know they are hypertensive

Interventions

normotensive patients

patients who do not have high blood pressure diagnosis and actual blood pressure is within the normal range

Intervention Type: PROCEDURE

patients with hypertension diagnosis

Patients who have high blood pressure diagnosis

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

yesim cetintas

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neval Boztug, Prof

Role: STUDY_DIRECTOR

Akdeniz University Medical School Anesthesiology and Reanimation Department

Locations

Akdeniz University Hospital

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AkdenizU-438

Identifier Type: -

Identifier Source: org_study_id