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Nasal PolypsAuriFESSNCT06182982

Auriculotherapy for Intraoperative Blood Pressure Control

A study testing auricolotherapy in people with Nasal Polyps and Anesthesia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Nasal Polyps, Anesthesia, Sinusitis
What is being tested?
auricolotherapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteItaly
Study dates
15 Jun 2024to 30 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Age < 18 years;
  • Pregnancy status;
  • NYHA class > III;
  • ASA class > III;
  • BMI > 35;
  • Positive history of Myocardial Infarction or neurovascular diseases;
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Fondazione Policlinico Gemelli IRCCS

    Rome, 00168

    Fabio Dr. Sbaraglia, Ph.D, 0039.06.3015.1 ext. 3288, fabio.sbaraglia@policlinicogemelli.it

    carmela.riso@policlinicogemelli.it

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Being tested
auricolotherapy
Medical subject headings
Nasal Polyps, Sinusitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • auricolotherapyDevice

    Magnetic bal plasters are applied on the ear surface

Study groups in NCT06182982
Study groupRoleWhat they receive
AuricolotherapyExperimentalPreoperative positioning of magnetic ball plasters for auricolotherpy.
Receives: Device: auricolotherapy
ControlSham comparatorEars will be covered by a band-aid (after a simulation of auricolotherapy)
Receives: Device: auricolotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nitroglycerin

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

    Measured: at the end of surgery

Secondary outcomes (2)
  1. Blood pressure

    Difference in blood pressure values between the two groups

    Measured: 24 hours

  2. Surgeon

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

    Measured: at the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2023
  2. Study start15 Jun 2024 (estimated)
  3. Primary completion15 Jul 2024 (estimated)
  4. Study completion30 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06182982
Sponsor's protocol ID
ID 5828
Acronym
AuriFESS
Status last verified
Dec 2023
First submitted
13 Dec 2023
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing auricolotherapy in people with Nasal Polyps and Anesthesia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fabio Sbaraglia, dr (+39063015 ext. 5701, fabio.sbaraglia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nitroglycerin (time frame: at the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

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