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

Completed

• Conditions: Arterial Stiffness; Spinal Anaesthesia; Hypertension
• Interventions: Procedure: PWV

• Registration Number: NCT05537246
• Lead Sponsor: Aydin Adnan Menderes University

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-07-26
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GROUP NORMO	PWV	As a result of 3 measurements and medical histories of the cases, those who did not use drugs effective on the cardiovascular system and whose SBP value was lower than 140 mmHg were called the normotensive group.
GROUP HT	PWV	In the preoperative evaluation, after arterial blood pressure measurement was made 3 times; Hypertension group was defined as the patients who did not use drugs that are effective on the cardiovascular system, whose SBP value was higher than 140 mmHg, or those who were diagnosed with hypertension and were using drugs with a SBP value higher than 140 mmHg.

Primary Outcome Measures

Name	Time	Method
Arterial blood pressure	1., 3., 5., 10., 20. minute	After spinal anesthesia, SBP, DBP, MAP, HR and SpO₂ values of all patients were recorded.

Trial Locations

Locations (2)

Sinan Yılmaz; 🇹🇷 Efeler, Aydın, Turkey

Aydin Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation; 🇹🇷 Aydin, Turkey