Status:

UNKNOWN

Auriculotherapy for Intraoperative Blood Pressure Control

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Nasal Polyps

Anesthesia

Eligibility:

All Genders

18-69 years

Phase:

NA

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, ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2024

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT06182982

Start Date

June 15 2024

End Date

July 30 2024

Last Update

January 3 2024

Active Locations (1)

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1

Fondazione Policlinico Gemelli IRCCS

Rome, Italy, 00168