Auriculotherapy for Intraoperative Blood Pressure Control (AuriFESS)

Efficacy of Auriculotherapy Medical Devices in Intraoperative Blood Pressure Control During Endoscopic Sinus Surgery, a Prospective Randomized Controlled Study.

The endoscopic surgery of the paranasal sinuses (FESS) requires careful control of arterial pressure to prevent bleeding of the nasal mucosa that may lead to a reduction in the visual field. However, controlled reversible hypotension has been associated with phenomena of peripheral hypoperfusion with possible organ damage on an ischemic basis. Based on the data available in the literature, a mean arterial pressure (MAP) target between 50 and 65 mmHg is considered acceptable. Although blood pressure control is generally ensured through intravenous pharmacological approaches, there is evidence of efficacy with the use of Auriculotherapy medical devices (stimulation of specific points in the ear through the application of Magnetic ball plasters).

Proposed pharmacological choices to achieve this result have been multiple, although totally intravenous anesthesia with propofol and opioids seems to be more effective than balanced anesthesia with halogenated agents and opioids. However, this fundamental option requires the administration of antihypertensive drugs to achieve the blood pressure target. Despite common contraindications to individual pharmacological classes, various active principles have been compared. Among these, continuous low-dose nitroglycerin infusion has proven effective due to titratability linked to its short half-life, perioperative complications, and better conditions of peripheral perfusion compared to beta-blockers such as labetalol or esmolol.

Based on existing literature data, in our hospital, general anesthesia is typically conducted with intravenous techniques and the continuous administration of low doses of nitroglycerin in continuous infusion (0.01-2 mcg/kg/min). Despite the low dosages, this drug can be burdened with dosage-dependent adverse effects such as orthostatic hypotension, tachycardia, or headache. To reduce the dosage of nitroglycerin, we have borrowed from different contexts hypotensive auriculotherapy techniques (stimulation of specific ear points through the application of magnetic ball plasters), which have proven effective in managing systemic pressure in patients with essential hypertension.

These non-pharmacological techniques, already used during general anesthesia for the management of nausea and pain, could prove promising in reducing the use of antihypertensive drugs even in the intraoperative context. The primary hypothesis of our study is that the use of Auriculotherapy medical devices is effective in achieving a hypotensive effect in patients undergoing general anesthesia during FESS surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Sinusitis; Nasal Polyps; Anesthesia; ENT Surgical Result - Nose Nasal Congestion
• Intervention / Treatment: Device: auricolotherapy

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Sbaraglia, dr; Phone Number: 5701 +39063015; Email: fabio.sbaraglia@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Gemelli IRCCS
    • Contact: Fabio Dr. Sbaraglia, Ph.D; Phone Number: 3288 0039.06.3015.1; Email: fabio.sbaraglia@policlinicogemelli.it
    • Contact: Email: carmela.riso@policlinicogemelli.it
    • Principal Investigator: Fabio Sbaraglia
    • Sub-Investigator: Carmela Riso
    • Sub-Investigator: Demetrio Del Prete
    • Sub-Investigator: Daniela Maria Micci
    • Sub-Investigator: Marco Rossi
    • Sub-Investigator: Giorgia Spinazzola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricolotherapy; Preoperative positioning of magnetic ball plasters for auricolotherpy.	Device: auricolotherapy; Magnetic bal plasters are applied on the ear surface
Sham Comparator: Control; Ears will be covered by a band-aid (after a simulation of auricolotherapy)	Device: auricolotherapy; Magnetic bal plasters are applied on the ear surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nitroglycerin	Reduction in the amount of intravenous nitroglycerin (mcg/kg/min) administered during FESS surgery	at the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Difference in blood pressure values between the two groups	24 hours
Surgeon	Subjective description by surgeon of the surgical field in terms of bleeding frequency	at the end of surgery

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Polyps; Sinusitis; Nasal Polyps
• Other Study ID Numbers: ID 5828

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No