Auriculotherapy for controlled hypotension during functional endoscopic surgery of the paranasal sinuses under general anesthesia: AuriFESS, a feasibility randomized pilot study

Background Administration of hypotensive drugs is common to induce controlled hypotension during surgery but dose-dependent side effects could limit their use. The primary hypothesis of our study is that the application of magnetic ball-plasters for auriculotherapy could be effective in achieving a hypotensive effect during general anesthesia. Methods Single-center, randomized controlled trial conducted in Italy between June and July 2024 and involving adult patients undergoing functional endoscopic sinus surgery (FESS). Magnetic ball plasters for auriculotherapy were applied to the treatment group (ATG), while a sham auriculotherapy was simulated for the control group (CG). Both groups received intravenous anesthesia with propofol and remifentanil and a continuous infusion of nitroglycerin was ensured to maintain a mean arterial pressure (MAP) between 60 and 70 mmHg. The primary outcome was the median intraoperative infusion rate of nitroglycerin, calculated as the total amount administered divided by patient body weight and duration of surgery. Secondary outcomes were: difference in MAP values between the two groups measured at predefined time points during the perioperative period and on first postoperative day; surgeon’s qualitative assessment of the surgical field in terms of bleeding. Results Among 50 patients enrolled, 40 were randomized and final analysis was completed on a sample of 33 patients. The ATG required lower doses of nitroglycerin compared with the CG to maintain MAP within target range, with a median infusion rate of 0.03 [IQR 0.01-0.07] μg/kg/min vs. 0.09 [IQR 0.04-0.16] μg/kg/min, respectively (P=0.041). Compared to baseline values, MAP significantly decreased in both groups during surgery (P <0.001), and controlled hypotension was maintained for the entire procedural time. At discharge from the recovery room and on first postoperative day MAP was comparable to preoperative values in both groups. No significant differences were reported in terms of qualitative assessment of the surgical field between the two cohorts. Conclusions In this randomized controlled trial auriculotherapy was effective in maintaining a hypotensive status during general anesthesia. Trial registration: Clinicaltrial.gov (NCT06182982), Principal investigator: Fabio Sbaraglia, Date of registration: December 13, 2023).