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

NCT05537246 | Completed DMC

• 1 other identifier: SpiASHT
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 2

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.

Conditions

Arterial Stiffness; Hypertension; Spinal Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Arterial blood pressure

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

  1., 3., 5., 10., 20. minute

Study Arms (2)

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

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

Interventions

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.

GROUP HT; GROUP NORMO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ASA I-II patients who will undergo elective lower extremity surgery under spinal anesthesia in the orthopedic operating room were selected.

You may qualify if:

• Undergoing elective lower extremity surgery
• years and over
• who agreed to participate in the study
• ASA I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (2)

Sinan Yılmaz

Efeler, Aydın, 09010, Turkey (Türkiye)

Location

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

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sinan Yılmaz

  institutional affiliation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: September 13, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)