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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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.

  1. 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)
  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.

  1. First posted18 Oct 2024
  2. Study start1 Sep 2024
  3. Primary completion1 Dec 2025
  4. Study completion1 Jun 2026

Resources

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
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

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.

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