Effect of Hypertension on Hemodynamics in the Prone Position

NCT06649487 | Enrolling By Invitation

• 1 other identifier: 24-KAEK-216
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension; Disk Herniation

Keywords

Anesthesia, General; Prone Position; Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• Cardiac output

  Cardiac output is how many liters of blood heart pumps in one minute.

  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)

  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).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Heart failure
• Severe arrhythmia
• Severe respiratory failure
• Renal failure
• Chronic liver disease
• Moderate and severe anemia
• Severe fluid and electrolyte disturbances
• Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
• Severe thyroid dysfunction
• Advanced psychiatric illness.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, Center, 600100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-11

Locations

TU (1)