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

Primary Purpose

Lumbar Disc Disease, Lumbar Spinal Stenosis, Lumbar Disc Herniation

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
normotensive patients
patients with hypertension diagnosis
patients who do not know they are hypertensive but actual blood pressure is high
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Disease focused on measuring transcranial doppler ultrasonography, high blood pressure, cerebral perfusion, prone position

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Akdeniz University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

normotensive patients

patients with high blood pressure diagnosis

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Mean cerebral perfusion pressure of hypertensive patients under anesthesia
Mean cerebral perfusion pressure will be measured by transcranial doppler ultrasonography under anesthesia

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2020
Last Updated
October 15, 2020
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04587401
Brief Title
The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
March 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Disease, Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Fracture
Keywords
transcranial doppler ultrasonography, high blood pressure, cerebral perfusion, prone position

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
normotensive patients
Arm Type
Experimental
Arm Description
Cerebral perfusion of normotensive patients who will have lumbar surgery at the prone position will be measured by transcranial doppler ultrasonography
Arm Title
patients with high blood pressure diagnosis
Arm Type
Experimental
Arm Description
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
Arm Title
patients who do not know they are hypertensive but actual blood pressure is high
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
normotensive patients
Intervention Description
patients who do not have high blood pressure diagnosis and actual blood pressure is within the normal range
Intervention Type
Procedure
Intervention Name(s)
patients with hypertension diagnosis
Intervention Description
Patients who have high blood pressure diagnosis
Intervention Type
Procedure
Intervention Name(s)
patients who do not know they are hypertensive but actual blood pressure is high
Intervention Description
patients with preoperative high blood pressure, who do not know they are hypertensive
Primary Outcome Measure Information:
Title
Mean cerebral perfusion pressure of hypertensive patients under anesthesia
Description
Mean cerebral perfusion pressure will be measured by transcranial doppler ultrasonography under anesthesia
Time Frame
time from the preoperative period of the surgery until the postoperative 24th hour of the surgery
Secondary Outcome Measure Information:
Title
Comparison of transcranial doppler and near-infrared spectroscopy for determining of cerebral perfusion
Description
Transcranial doppler and near-infrared spectroscopy measurements will be compared by neurocognitive tests after the surgery
Time Frame
time from the preoperative period of the surgery until the postoperative 24th hour of the surgery
Other Pre-specified Outcome Measures:
Title
Determination of changes of the cerebral perfusion in patients with actual high blood pressure who has not been diagnosed for hypertension before.
Description
Mean cerebral arterial pressure of patients with actual high blood pressure but without hypertension diagnosis will be measured by transcranial doppler ultrasonography
Time Frame
time from the preoperative period of the surgery until the postoperative 24th hour of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yesim Cetintas, Specialist
Phone
00902422496257
Ext
6260
Email
yesimcetintas@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ela Atmaca Kaplan, MD
Phone
00902422496257
Ext
6260
Email
elaatmaca1909@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neval Boztug, Prof
Organizational Affiliation
Akdeniz University Medical School Anesthesiology and Reanimation Department
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University Hospital
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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