Clinical trial NCT05537246: The Relationship Between Arterial Stiffness and Hemodynamic Responses in Patients With Spinal Anesthesia
Official title: The Importance of Preoperative Arterial Stiffness Measurement in Predicting Hemodynamic Changes in Hypertensive and Normotensive Patients Undergoing Spinal Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
Hypertension
Spinal Anaesthesia
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA I-II patients who will undergo elective lower extremity surgery under spinal anesthesia in the orthopedic operating room were selected.

Brief summary: The aim of this study is to investigate the importance of pulse wave velocity, an indicator of arterial stiffness, in predicting hemodynamic changes in normotensive and hypertensive patients undergoing spinal anesthesia.

Detailed description: The prospective cross-sectional study will be carried out between September 1, 2021 and September 1, 2022 at Aydin Adnan Menderes University Faculty of Medicine. Patients aged eighteen and over who will undergo lower extremity surgery under spinal anesthesia will be included in the study.

During the preoperative evaluation, the patient will be asked about age, weight, height, smoking and alcohol use history. At the same time, hypertension disease (if any, drugs used), diabetes (if any, drugs used), hyperlipidemia (if any, drugs used) and other diseases and drugs used will be recorded.

Before surgery, hemodynamic data (systolic arterial blood pressure, diastolic arterial blood pressure, mean arterial blood pressure, heart rate and oxygen saturation), arterial stiffness measurement (pulse wave velocity) will be evaluated in the patient preparation room. Arterial stiffness measurement will be made with the oscillometric mobil-o-graph device in the anesthesia department.

Hemodynamic data is recorded by the anesthesia device 1.,3.,5.,10.,20. minutes during surgery. Intraoperative hypotension is accepted as a 20% reduction in systolic arterial blood pressure evaluated before anesthesia. Using this data recorded on the monitor, reductions of 20% or more in systolic arterial blood pressure will be recorded as hypotension.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective lower extremity surgery
* 18 years and over
* who agreed to participate in the study
* ASA I-II

Exclusion Criteria:

* Undergoing cardiovascular or neurological surgery within 6 months
* Unwilling to participate in the study
* Undergoing prosthetic valve surgery
* Vasculitis
* Peripheral artery disease
* Under the age of 18
* Conditions in which spinal anesthesia is contraindicated

Primary outcomes:
measure: Arterial blood pressure
timeFrame: 1., 3., 5., 10., 20. minute
Secondary outcomes:
Other outcomes:
Locations:
city: Efeler
country: Turkey
facility: Sinan Yılmaz
state: Aydın
city: Aydin
country: Turkey
facility: Aydin Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation
Study officials:
affiliation: institutional affiliation
name: Sinan Yılmaz
role: PRINCIPAL_INVESTIGATOR
References: