ClinicalTrials.gg
Not yet recruitingNCT06182982AuriFESSUpdated Jan 3, 2024

Auriculotherapy for Intraoperative Blood Pressure Control

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

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nasal Polyps
  • Anesthesia
  • Sinusitis
  • ENT Surgical Result - Nose Nasal Congestion
03

In context

Nasal Polyps

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 →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age \< 18 years;
  • Pregnancy status;
  • class > III;
  • > III;
  • > 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 or inability to express it
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Auricolotherapy

    Preoperative positioning of magnetic ball plasters for auricolotherpy.

    Device: auricolotherapy

  • Sham comparator
    Control

    Ears will be covered by a band-aid (after a simulation of auricolotherapy)

    Device: auricolotherapy

Interventions

  • Deviceauricolotherapy

    Magnetic bal plasters are applied on the ear surface

06

What researchers measure

Primary outcomes

  1. Nitroglycerin

    Reduction in the amount of intravenous nitroglycerin (mcg/kg/min) administered during FESS surgery

    Time frame: at the end of surgery

Secondary outcomes

  1. Blood pressure

    Difference in blood pressure values between the two groups

    Time frame: 24 hours

  2. Surgeon

    Subjective description by surgeon of the surgical field in terms of bleeding frequency

    Time frame: at the end of surgery

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2024; primary completion for Jul 2024, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2023
First posted
Dec 27, 2023
StartEst.
Jun 15, 2024
Primary completionEst.
Jul 15, 2024
CompletionEst.
Jul 30, 2024
Last update
Jan 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06182982
Responsible party
Sponsor
First posted
Dec 27, 2023
Start date
Jun 15, 2024 (estimated)
Primary completion
Jul 15, 2024 (estimated)
Completion
Jul 30, 2024 (estimated)
Last update
Jan 3, 2024

Study contacts

Fabio Sbaraglia, dr
Contact
fabio.sbaraglia@policlinicogemelli.it
+39063015 ext. 5701

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion