Auricular Neuromodulation for FESS

ID#: NCT06662422

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 24, 2024

End Date: March 30, 2025

Contact Information:
Daniel Katz, MD
(212) 241-7475
Samuel DeMaria, MD
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.
Eligibility:

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
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