HypertensionNCT06649487
Effect of Hypertension on Hemodynamics in the Prone Position
An observational study of Hypertension and Disk Herniation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Long-term use of antihypertensive drugs in patients diagnosed with hypertension may cause sharp fluctuations in the patient's hemodynamic values such as blood pressure during anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Disk Herniation
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prone position may cause some hemodynamic changes in patients with hypertension compared to those without comorbidities. Therefore, in this study, researchers planned to investigate the changes in some hemodynamic values in patients with hypertension and without comorbidities who were scheduled for vertebral surgery. When calculating the sample size; a previous study has shown that the cardiac index is 2.5±0.3 with a change in prone position under general anesthesia. By estimating a change of approximately 10% in this value in patients with hypertension, when the type 1 error value is accepted as 0.05 and the power is 0.90, it has been determined that the sample size for the study is sufficient with 64 patients. Considering the losses that may occur during follow-up, it is planned to conduct the study with 70 patients with a 10% increase.
Who may be able to join
- Patients with ASA scores between 1 and 3 who wish to participate in the study.
- Patients between the ages of 18-75 who are scheduled for vertebral surgery
Who cannot join
- Heart failure
- Severe arrhythmia
- Severe respiratory failure
- Renal failure
- Chronic liver disease
- Moderate and severe anemia
Show all 10Show fewer
- Severe fluid and electrolyte disturbances
- Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
- Severe thyroid dysfunction
- Advanced psychiatric illness.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Center, 600100
About this study
Official title: Investigation of the Effect of Hypertension on Hemodynamics in the Prone Position
Long-term use of antihypertensive drugs in patients diagnosed with hypertension may cause sharp fluctuations in the patient's hemodynamic values such as blood pressure during anesthesia. Low blood pressure that occurs during surgery may cause serious organ failure and even death, especially in patients in the prone position.
These conditions resulting from hypotension increase with prolonged exposure to hypotension. Therefore, it is very important to predict and prevent hypotension in spinal surgery.
In patients with hypertension, the prone position may cause some hemodynamic changes compared to those without comorbidities. Therefore, in this study, researchers planned to investigate the changes in some hemodynamic values in patients with hypertension and without comorbidities who were scheduled for spinal surgery.
Read the detailed description
The number of spine surgeries has increased in recent years due to degenerative diseases of the spine and age. Lumbar spine surgery is a surgery performed in the prone position. Changing the patient's position from supine to prone may cause a decrease in cardiac output, arterial pressure and tissue perfusion due to the decrease in the preload of the heart. In addition to the decrease in venous return due to increased intra-abdominal pressure, left ventricular compliance may be impaired due to increased thoracic pressure. All these changes may cause decreased cardiac output and systemic hypotension. These changes may be more pronounced especially with the prone position accompanied by anesthesia. This situation is thought to be due to the fact that anesthetic drugs cause direct hypotension as well as impairing reflex responses to hypotension such as the sympathetic system. Perioperative cardiac complications are the main causes of mortality after non-cardiac surgery. Intraoperative hypotension, especially in patients in the prone position, has been shown to be significantly associated with clinical outcomes such as spinal cord ischemia and postoperative vision loss and may lead to serious complications. Therefore, optimization of hemodynamic variables is an integral part of perioperative care to reduce postoperative mortality and morbidity during surgeries that require patients to be placed in the prone position, such as vertebral surgery.
More than 280 million surgeries are performed worldwide each year, and approximately one-third of these patients use antihypertensive agents before surgery. It has been reported that hypertension is associated with hypotension, especially after induction, in patients receiving general anesthesia. Therefore, it has been stated that perioperative management of patients receiving antihypertensive drugs is especially important. Patients diagnosed with preoperative hypertension have been associated with increased risk of surgical bleeding, stroke, and cardiovascular complications. Long-term use of antihypertensive drugs in hypertensive patients may cause autonomic nerve dysfunction, leading to perioperative hypovolemia, decreased tolerance to postural changes, and sharp fluctuations in circulation. Therefore, maintaining hemodynamic stability in hypertensive patients receiving general anesthesia may be difficult. The change in prone position required for vertebral surgery may be associated with a high risk of developing hypotension due to decreased venous return from inferior vena cava compression and increased intrathoracic pressure. In awake patients, hypotension caused by changes in position is prevented by baroreceptor reflex and sympathetic activation, whereas in anesthetized patients, anesthetic drugs may block these compensatory mechanisms, potentially increasing the incidence of hypotension associated with postural change. It has been reported that the incidence of hypotension associated with the change from supine to prone position under general anesthesia is approximately three times higher than in awake patients. However, there are also studies reporting that perioperative hemodynamic changes in patients with hypertension are similar to those without additional comorbidities. MostCare (Vytech Health™, Vygon, Padova, Italy) is a self-calibrating device based on continuous analysis of the systolic and diastolic phases of the arterial waveform via an intraarterial catheter. In short, this monitoring method provides valuable information in terms of cardiac and vascular functions and intravascular volume, as well as close monitoring of blood pressure. It is an important guide in the rapid recognition of etiology and treatment of hemodynamic changes. Spine surgery is mostly performed in the prone position and under general anesthesia. Both general anesthesia and prone position can cause significant changes in the patient's hemodynamics. However, there are limited studies on hemodynamic changes during anesthesia of patients diagnosed with hypertension, and their results are contradictory. In this study, researchers aimed to investigate the effect of hypertension on cardiovascular and hemodynamic changes in the prone position.
- Conditions
- Hypertension, Disk Herniation
- Keywords
- Anesthesia, General, Prone Position, Hemodynamic Monitoring
- Medical subject headings
- Hypertension, Intervertebral Disc Displacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Cardiac output is how many liters of blood heart pumps in one minute.
Measured: Hemodynamic parameters will be recorded 1 minute before prone position (T1), 1 minute after prone position (T2), 5 minutes after prone position (T3), 15 minutes after prone position (T4), 30 minutes after prone position (T5) and skin incision time (T6).
Secondary outcomes (1)
Blood pressure (systolic, diastolic and mean)
Systolic pressure is the maximum blood pressure during contraction of the ventricles; diastolic pressure is the minimum pressure recorded just prior to the next contraction. The mean arterial pressure (MAP) is the average arterial pressure throughout one cardiac cycle, systole, and diastole. The unit of measurement of blood pressure is mmHg.
Measured: Hemodynamic parameters will be recorded 1 minute before prone position (T1), 1 minute after prone position (T2), 5 minutes after prone position (T3), 15 minutes after prone position (T4), 30 minutes after prone position (T5) and skin incision time (T6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Genc, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649487
- Sponsor's protocol ID
- 24-KAEK-216
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Hypertension on Hemodynamics in the Prone Position
- ClinicalTrials.gov ID
- NCT06649487
- Acronym / sponsor ID
- 24-KAEK-216
- Conditions
- Hypertension, Disk Herniation
- Keywords
- Anesthesia, General, Prone Position, Hemodynamic Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 18 Oct 2024 (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.
Long-term use of antihypertensive drugs in patients diagnosed with hypertension may cause sharp fluctuations in the patient's hemodynamic values such as blood pressure during anesthesia. Low blood pressure that occurs during surgery may cause serious organ failure and even death, especially in patients in the prone position.
These conditions resulting from hypotension increase with prolonged exposure to hypotension. Therefore, it is very important to predict and prevent hypotension in spinal surgery.
In patients with hypertension, the prone position may cause some hemodynamic changes compared to those without comorbidities. Therefore, in this study, researchers planned to investigate the changes in some hemodynamic values in patients with hypertension and without comorbidities who were scheduled for spinal surgery.
Detailed description
The number of spine surgeries has increased in recent years due to degenerative diseases of the spine and age. Lumbar spine surgery is a surgery performed in the prone position. Changing the patient's position from supine to prone may cause a decrease in cardiac output, arterial pressure and tissue perfusion due to the decrease in the preload of the heart. In addition to the decrease in venous return due to increased intra-abdominal pressure, left ventricular compliance may be impaired due to increased thoracic pressure. All these changes may cause decreased cardiac output and systemic hypotension. These changes may be more pronounced especially with the prone position accompanied by anesthesia. This situation is thought to be due to the fact that anesthetic drugs cause direct hypotension as well as impairing reflex responses to hypotension such as the sympathetic system. Perioperative cardiac complications are the main causes of mortality after non-cardiac surgery. Intraoperative hypotension, especially in patients in the prone position, has been shown to be significantly associated with clinical outcomes such as spinal cord ischemia and postoperative vision loss and may lead to serious complications. Therefore, optimization of hemodynamic variables is an integral part of perioperative care to reduce postoperative mortality and morbidity during surgeries that require patients to be placed in the prone position, such as vertebral surgery.
More than 280 million surgeries are performed worldwide each year, and approximately one-third of these patients use antihypertensive agents before surgery. It has been reported that hypertension is associated with hypotension, especially after induction, in patients receiving general anesthesia. Therefore, it has been stated that perioperative management of patients receiving antihypertensive drugs is especially important. Patients diagnosed with preoperative hypertension have been associated with increased risk of surgical bleeding, stroke, and cardiovascular complications. Long-term use of antihypertensive drugs in hypertensive patients may cause autonomic nerve dysfunction, leading to perioperative hypovolemia, decreased tolerance to postural changes, and sharp fluctuations in circulation. Therefore, maintaining hemodynamic stability in hypertensive patients receiving general anesthesia may be difficult. The change in prone position required for vertebral surgery may be associated with a high risk of developing hypotension due to decreased venous return from inferior vena cava compression and increased intrathoracic pressure. In awake patients, hypotension caused by changes in position is prevented by baroreceptor reflex and sympathetic activation, whereas in anesthetized patients, anesthetic drugs may block these compensatory mechanisms, potentially increasing the incidence of hypotension associated with postural change. It has been reported that the incidence of hypotension associated with the change from supine to prone position under general anesthesia is approximately three times higher than in awake patients. However, there are also studies reporting that perioperative hemodynamic changes in patients with hypertension are similar to those without additional comorbidities. MostCare (Vytech Health™, Vygon, Padova, Italy) is a self-calibrating device based on continuous analysis of the systolic and diastolic phases of the arterial waveform via an intraarterial catheter. In short, this monitoring method provides valuable information in terms of cardiac and vascular functions and intravascular volume, as well as close monitoring of blood pressure. It is an important guide in the rapid recognition of etiology and treatment of hemodynamic changes. Spine surgery is mostly performed in the prone position and under general anesthesia. Both general anesthesia and prone position can cause significant changes in the patient's hemodynamics. However, there are limited studies on hemodynamic changes during anesthesia of patients diagnosed with hypertension, and their results are contradictory. In this study, researchers aimed to investigate the effect of hypertension on cardiovascular and hemodynamic changes in the prone position.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prone position may cause some hemodynamic changes in patients with hypertension compared to those without comorbidities. Therefore, in this study, researchers planned to investigate the changes in some hemodynamic values in patients with hypertension and without comorbidities who were scheduled for vertebral surgery. When calculating the sample size; a previous study has shown that the cardiac index is 2.5±0.3 with a change in prone position under general anesthesia. By estimating a change of approximately 10% in this value in patients with hypertension, when the type 1 error value is accepted as 0.05 and the power is 0.90, it has been determined that the sample size for the study is sufficient with 64 patients. Considering the losses that may occur during follow-up, it is planned to conduct the study with 70 patients with a 10% increase.
Key inclusion criteria (2 listed)
- Patients with ASA scores between 1 and 3 who wish to participate in the study.
- Patients between the ages of 18-75 who are scheduled for vertebral surgery
Key exclusion criteria (10 listed)
- Heart failure
- Severe arrhythmia
- Severe respiratory failure
- Renal failure
- Chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac output
Time frame: Hemodynamic parameters will be recorded 1 minute before prone position (T1), 1 minute after prone position (T2), 5 minutes after prone position (T3), 15 minutes after prone position (T4), 30 minutes after prone position (T5) and skin incision time (T6).
Cardiac output is how many liters of blood heart pumps in one minute.
1 secondary outcome
Blood pressure (systolic, diastolic and mean)
Time frame: Hemodynamic parameters will be recorded 1 minute before prone position (T1), 1 minute after prone position (T2), 5 minutes after prone position (T3), 15 minutes after prone position (T4), 30 minutes after prone position (T5) and skin incision time (T6).
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 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Disk Herniation, run by Tokat Gaziosmanpasa 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?
The sponsor lists 2 inclusion and 10 exclusion criteria. 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 1 Jul 2026. 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?
Cardiac output (time frame: Hemodynamic parameters will be recorded 1 minute before prone position (T1), 1 minute after prone position (T2), 5 minutes after prone position (T3), 15 minutes after prone position (T4), 30 minutes after prone position (T5) and skin incision time (T6).). 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 1 Jul 2026.