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.
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;
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- 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
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 group | Role | What they receive |
|---|---|---|
| Auricolotherapy | Experimental | Preoperative positioning of magnetic ball plasters for auricolotherpy. Receives: Device: auricolotherapy |
| Control | Sham comparator | Ears 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.
Nitroglycerin
Reduction in the amount of intravenous nitroglycerin (mcg/kg/min) administered during FESS surgery
Measured: at the end of surgery
Secondary outcomes (2)
Blood pressure
Difference in blood pressure values between the two groups
Measured: 24 hours
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.
- First posted27 Dec 2023
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Auriculotherapy Medical Devices in Intraoperative Blood Pressure Control During Endoscopic Sinus Surgery, a Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06182982
- Acronym / sponsor ID
- AuriFESS / ID 5828
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricolotherapy | Experimental | Device: auricolotherapyPreoperative positioning of magnetic ball plasters for auricolotherpy. |
| Control | Sham comparator | Device: auricolotherapyEars will be covered by a band-aid (after a simulation of auricolotherapy) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- Age < 18 years;
- Pregnancy status;
- NYHA class > III;
- ASA class > III;
- BMI > 35;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricolotherapyMagnetic bal plasters are applied on the ear surface | Device | Auricolotherapy, Control |
Primary outcome
Nitroglycerin
Time frame: at the end of surgery
Reduction in the amount of intravenous nitroglycerin (mcg/kg/min) administered during FESS surgery
2 secondary outcomes
Blood pressure
Time frame: 24 hours
Surgeon
Time frame: at the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.