Auriculotherapy for Intraoperative Blood Pressure Control

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method called Auriculotherapy to help control blood pressure during a specific type of surgery known as Functional Endoscopic Sinus Surgery (FESS). Maintaining the right blood pressure during this surgery is important to prevent complications like bleeding. Traditionally, doctors use medications to manage blood pressure, but this trial aims to see if stimulating certain points on the ear with special magnetic patches can also effectively lower blood pressure without relying as heavily on drugs.

To participate in this trial, you need to be between the ages of 18 and 69 and have well-managed high blood pressure that has been treated with medication for at least a year. You also need to be scheduled for FESS surgery under general anesthesia. If you have certain health conditions or allergies, you may not be eligible. If you join the study, you'll help researchers understand if this ear stimulation technique can safely help control blood pressure during surgery, potentially reducing the need for other medications.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Patients of both sexes to undergo Functional Endoscopic Sinus Surgery (FESS) under General Anesthesia
• • Patients aged between 18 and 69 years
• • History of well-controlled essential hypertension under pharmacological treatment for at least one year
• • ASA Class II-III.
• Exclusion Criteria:
• • Age \< 18 years;
• • Pregnancy status;
• • NYHA class \> III;
• • ASA class \> III;
• • BMI \> 35;
• • Positive history of Myocardial Infarction or neurovascular diseases;
• • Previous treatment with antineoplastic agents;
• • Secondary hypertension;
• • Uncontrolled hypertension despite therapy (MAP \> 125 in preoperative visit);
• • Anatomic alterations of the auricles;
• • Presence of carotid stenosis \> 50%;
• • Allergy or intolerance to drugs specified in the clinical protocol;
• • Nickel or metal allergy present in magnetic spheres;
• • Refusal of informed consent or inability to express it