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

NCT ID: NCT05537246

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-09-01

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.

Conditions

Arterial Stiffness; Hypertension; Spinal Anaesthesia

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

GROUP HT

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.

PWV

Intervention Type: 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.

GROUP NORMO

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.

PWV

Intervention Type: 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.

Interventions

PWV

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

SİNAN YILMAZ

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sinan Yılmaz

Role: PRINCIPAL_INVESTIGATOR

institutional affiliation

Locations

Sinan Yılmaz

Efeler, Aydın, Turkey (Türkiye)

Aydin Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation

Aydin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SpiASHT

Identifier Type: -

Identifier Source: org_study_id