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Auriculotherapy for Intraoperative Blood Pressure Control

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06182982
Acronym
AuriFESS
Enrollment
32
Registered
2023-12-27
Start date
2024-06-15
Completion date
2024-07-30
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, ENT Surgical Result - Nose Nasal Congestion, Nasal Polyps, Sinusitis

Brief summary

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.

Interventions

DEVICEauricolotherapy

Magnetic bal plasters are applied on the ear surface

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Nitroglycerinat the end of surgeryReduction in the amount of intravenous nitroglycerin (mcg/kg/min) administered during FESS surgery

Secondary

MeasureTime frameDescription
Blood pressure24 hoursDifference in blood pressure values between the two groups
Surgeonat the end of surgerySubjective description by surgeon of the surgical field in terms of bleeding frequency

Countries

Italy

Contacts

Primary ContactFabio Sbaraglia, dr
fabio.sbaraglia@policlinicogemelli.it+39063015

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026