Lumbar Disc DiseaseNCT04587401
The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure
A study testing normotensive patients, patients with hypertension diagnosis and patients who do not know they are hypertensive but actual blood pressure is high in people with Lumbar Disc Disease and Lumbar Spinal Stenosis, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Disease, Lumbar Spinal Stenosis, Lumbar Disc Herniation
- What is being tested?
- normotensive patients, patients with hypertension diagnosis and patients who do not know they are hypertensive but actual blood pressure is high
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 2 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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.
- Being tested
- normotensive patients, patients with hypertension diagnosis, patients who do not know they are hypertensive but actual blood pressure is high
- Keywords
- transcranial doppler ultrasonography, high blood pressure, cerebral perfusion, prone position
- Medical subject headings
- Intervertebral disc disease, Spinal Stenosis, Intervertebral Disc Displacement, Fractures, Bone, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normotensive patientsProcedure or surgery
patients who do not have high blood pressure diagnosis and actual blood pressure is within the normal range
patients with hypertension diagnosisProcedure or surgery
Patients who have high blood pressure diagnosis
patients who do not know they are hypertensive but actual blood pressure is highProcedure or surgery
patients with preoperative high blood pressure, who do not know they are hypertensive
| Study group | Role | What they receive |
|---|---|---|
| normotensive patients | Experimental | Cerebral perfusion of normotensive patients who will have lumbar surgery at the prone position will be measured by transcranial doppler ultrasonography Receives: 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 Receives: 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 Receives: Procedure: patients who do not know they are hypertensive but actual blood pressure is high |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cerebral perfusion pressure of hypertensive patients under anesthesia
Mean cerebral perfusion pressure will be measured by transcranial doppler ultrasonography under anesthesia
Measured: 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
Transcranial doppler and near-infrared spectroscopy measurements will be compared by neurocognitive tests after the surgery
Measured: time from the preoperative period of the surgery until the postoperative 24th hour of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2020
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yesim cetintas, Akdeniz University
- Investigators
- Neval Boztug, Prof, Study director, Akdeniz University Medical School Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587401
- Sponsor's protocol ID
- AkdenizU-438
- Status last verified
- Sep 2020
- First submitted
- 8 Oct 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04587401
- Acronym / sponsor ID
- AkdenizU-438
- Keywords
- transcranial doppler ultrasonography, high blood pressure, cerebral perfusion, prone position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| normotensive patients | Experimental | Procedure: normotensive patientsCerebral perfusion of normotensive patients who will have lumbar surgery at the prone position will be measured by transcranial doppler ultrasonography |
| patients with high blood pressure diagnosis | Experimental | Procedure: patients with hypertension diagnosisCerebral perfusion of patients with high blood pressure diagnosis who will have lumbar surgery at the prone position will be measured by transcranial doppler ultrasonography |
| patients who do not know they are hypertensive but actual blood pressure is high | Experimental | Procedure: patients who do not know they are hypertensive but actual blood pressure is highcerebral 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normotensive patientspatients who do not have high blood pressure diagnosis and actual blood pressure is within the normal range | Procedure or surgery | normotensive patients |
| patients with hypertension diagnosisPatients who have high blood pressure diagnosis | Procedure or surgery | patients with high blood pressure diagnosis |
| patients who do not know they are hypertensive but actual blood pressure is highpatients with preoperative high blood pressure, who do not know they are hypertensive | Procedure or surgery | patients who do not know they are hypertensive but actual blood pressure is high |
Primary outcome
Mean cerebral perfusion pressure of hypertensive patients under anesthesia
Time frame: 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
1 secondary outcome
Comparison of transcranial doppler and near-infrared spectroscopy for determining of cerebral perfusion
Time frame: time from the preoperative period of the surgery until the postoperative 24th hour of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neval Boztug, Prof study director
Akdeniz University Medical School Anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normotensive patients, patients with hypertension diagnosis and patients who do not know they are hypertensive but actual blood pressure is high in people with Lumbar Disc Disease and Lumbar Spinal Stenosis, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cerebral perfusion pressure of hypertensive patients under anesthesia (time frame: time from the preoperative period of the surgery until the postoperative 24th hour of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.