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

Hypertension Clinical Trial

— SpiASHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05537246
• Other study ID #: SpiASHT
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2024
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• Hypertension
• Spinal Anaesthesia

Intervention

Procedure:
• PWV
All cases were evaluated in the service before surgery. Pulse wave velocity measurement was performed with the MOBIL-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.

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation	Aydin
Turkey	Sinan Yilmaz	Efeler	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial blood pressure	After spinal anesthesia, SBP, DBP, MAP, HR and SpO2 values of all patients were recorded.	1., 3., 5., 10., 20. minute