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

Sponsor

Aydin Adnan Menderes University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05537246

Collaborator

(none)

150

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Stiffness Hypertension Spinal Anaesthesia	Procedure: PWV

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: 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.
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.	Procedure: 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.

Arm

Intervention/Treatment

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.

Procedure: 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.

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.

Procedure: PWV

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sinan Yılmaz	Efeler	Aydın	Turkey	09010
2	Aydin Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation	Aydin		Turkey	09100

Sponsors and Collaborators

Aydin Adnan Menderes University

Investigators

Principal Investigator: Sinan Yılmaz, institutional affiliation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SİNAN YILMAZ, Associate Professor, Aydin Adnan Menderes University

ClinicalTrials.gov Identifier:

NCT05537246

Other Study ID Numbers:

SpiASHT

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Sep 13, 2022