CompletedNot Applicable

Auricular Neuromodulation for FESS

United States20 participantsStarted 2024-10-23

Plain-language summary

In this blinded prospective randomized control trial the researchers will investigate the impact of cutaneous vagal nerve stimulation on surgical conditions in patients undergoing functional and ascorbic sinus surgery (FESS). The device is an externally placed vagal nerve stimulator. The device will be applied to participants after consent and induction of anesthesia. The study team will open the randomization envelope and if the participant is assigned to stimulation the device will be turned on. In the case that the participant is assigned to the control arm, the device will be set to sham. The device will remain on for 30 minutes and removed before entering the OR. Device will be reinserted in the recovery room for another 30 minutes.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA 1 and 2 * Presenting for elective FESS surgery Exclusion Criteria: * Anti-fibrinolytic use within 30 days of enrollment * Known or acquired coagulation disorders * Hypercoagulable state, including morbid obesity and active smoking * Pregnancy * Blood transfusion with 30 days of enrollment * History of epileptic seizures * Presence of device such as pacemaker, cochlear prosthesis, neurostimulator * Ear infection * Abnormal ear anatomy which inhibits application of device * Presence of other significant disease or disorder which under the discretion of the principal investigator could influence the results of the trial or the participant's ability to participate in the trial

What they're measuring

Boezaart Score

Timeframe: every 15 minutes during surgical procedure

Trial details

NCT IDNCT06662422

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-18