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Completed

NCT Number: NCT05537246

The Relationship Between Arterial Stiffness and Hemodynamic Responses in Patients With Spinal Anesthesia

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sinan Yılmaz, Efeler, Aydın, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PWV

Procedure

All cases were evaluated in the service before surgery. Pulse wave velocity measurement was performed with the MOBİL-O-GRAPH device, which is one of the noninvasive methods. Before measuring from patients; It was confirmed that there was no coffee/cigarette consumption within 30 minutes. After resting for 5 minutes in a quiet room, the cuff of the appropriate size was tied to the arm in such a way that it came to the brachial artery. The data recorded by the tonometer was transferred to the computer program. Care was taken that the patient did not move or talk during the measurement.

Primary outcomes

  1. Arterial blood pressure

    Time frame: 1., 3., 5., 10., 20. minute

    After spinal anesthesia, SBP, DBP, MAP, HR and SpO₂ values of all patients were recorded.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Importance of Preoperative Arterial Stiffness Measurement in Predicting Hemodynamic Changes in Hypertensive and Normotensive Patients Undergoing Spinal Anaesthesia

Acronym: SpiASHT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2022
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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