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

NCT04587401 | Completed

• 1 other identifier: AkdenizU-438
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

transcranial doppler ultrasonography; high blood pressure; cerebral perfusion; prone position

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• 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

Study Arms (3)

normotensive patients

EXPERIMENTAL

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

Procedure: normotensive patients

patients with high blood pressure diagnosis

EXPERIMENTAL

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

Procedure: patients with hypertension diagnosis

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

EXPERIMENTAL

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

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

Interventions

normotensive patients PROCEDURE

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

normotensive patients

patients with hypertension diagnosis PROCEDURE

Patients who have high blood pressure diagnosis

patients with high blood pressure diagnosis

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral disc disease; Spinal Stenosis; Intervertebral Disc Displacement; Fractures, Bone; Hypertension

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Neval Boztug, Prof

  Akdeniz University Medical School Anesthesiology and Reanimation Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients with mental retardation, with brain tumor, head trauma, cerebral aneurysm, cerebrovascular accident, dementia, psychiatric disease, and carotid stenosis were excluded from the study.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 14, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: March 2, 2021
• Last Updated: February 29, 2024

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)