An interventional study of auricolotherapy in Nasal Polyps, Anesthesia and Sinusitis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
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.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's planned enrollment of 32 is below the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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The New York Heart Association’s four classes of how much heart failure limits physical activity.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preoperative positioning of magnetic ball plasters for auricolotherpy.
Device: auricolotherapy
Ears will be covered by a band-aid (after a simulation of auricolotherapy)
Device: auricolotherapy
Magnetic bal plasters are applied on the ear surface
Nitroglycerin
Reduction in the amount of intravenous nitroglycerin (mcg/kg/min) administered during FESS surgery
Time frame: at the end of surgery
Blood pressure
Difference in blood pressure values between the two groups
Time frame: 24 hours
Surgeon
Subjective description by surgeon of the surgical field in terms of bleeding frequency
Time frame: at the end of surgery
Start is estimated for Jun 2024; primary completion for Jul 2024, 1 month later.
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