- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05155514
Pulse Wave Velocity and Hemodynamic Response During Anesthesia Induction in Hypertensive Patients (AS)
Comparison of the Relationship Between Preoperatively Measured Pulse Wave Velocity and Hemodynamic Changes During Anesthesia Induction in Hypertensive and Normotensive Patients.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aydın, Turkey, 09100
- Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group H
Hypertension group (Group H):
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After resting in a quiet room preoperatively, blood pressure was measured on the right arm using an oscillometric method.
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Group N
Normotensive group (Group N): Other non-hypertensive patients
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After resting in a quiet room preoperatively, blood pressure was measured on the right arm using an oscillometric method.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference between hemodynamic values
Time Frame: Basal measurement before induction of anesthesia, then at 1-minute intervals until after endotracheal intubation
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The difference between the hemodynamic values measured preoperatively and during anesthesia induction was calculated.
In addition, ≥20% decrease in preoperative hemodynamic value and/or systolic blood pressure ≤90 mmHg hypotension, ≥20% increased hypertension
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Basal measurement before induction of anesthesia, then at 1-minute intervals until after endotracheal intubation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Arterial stiffness
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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