Pulse Wave Velocity and Hemodynamic Response During Anesthesia Induction in Hypertensive Patients

NCT ID: NCT05155514

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hypertension is a disease with increasing and serious complications all over the world. In particular, the incidence of hypertension increases with advancing age. Secondary problems that can be caused by hypertension include peripheral vascular diseases, arteriosclerosis, increased risk of heart attack and stroke. It is a measurement of pulse wave velocity (PWV), a non-invasive indicator of arterial stiffness. It is known that sudden hemodynamic changes that occur during the induction of anesthesia cause undesirable intraoperative and postoperative complications. It is known that arterial stiffness, which is more common in elderly patients, causes orthostatic hypotension in particular. For this reason, more hemodynamic instability may be seen in the general anesthesia procedure in elderly patients with increased arterial stiffness.

In our study, we aimed to investigate whether the hemodynamic changes observed during anesthesia induction in hypertensive elderly patients, whom we think have a high pulse wave velocity, are different from normotensive patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arterial Stiffness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group H

Hypertension group (Group H):

* Patients with a previous diagnosis of hypertension
* Patients receiving antihypertensive therapy
* Systolic blood pressure (SBP) ≥140mmHg and/or diastolic blood pressure (DBP) ≥90mmHg

Mobil-O-Graph PWA

Intervention Type PROCEDURE

After resting in a quiet room preoperatively, blood pressure was measured on the right arm using an oscillometric method.

Group N

Normotensive group (Group N): Other non-hypertensive patients

Mobil-O-Graph PWA

Intervention Type PROCEDURE

After resting in a quiet room preoperatively, blood pressure was measured on the right arm using an oscillometric method.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mobil-O-Graph PWA

After resting in a quiet room preoperatively, blood pressure was measured on the right arm using an oscillometric method.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* According to the American Society of Anesthesiologists (ASA), physical condition I-II,
* Elective otolaryngology surgery with endotracheal intubation planned
* Patients aged 50 and over

Exclusion Criteria

* Hypersensitivity to drugs
* Difficult intubation history
* Diabetes mellitus receiving insulin therapy
* Chronic renal failure or end-stage renal disease
* Heart failure (left ventricular ejection fraction ≤30%)
* Valve disease (moderate to severe)
* Atrial fibrillation
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SİNAN YILMAZ

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Aydin, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Arterial stiffness

Identifier Type: -

Identifier Source: org_study_id