Auricular Neuromodulation for FESS

Description

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.

Conditions

Functional Endoscopic Sinus Surgery, Vagal Nerve Stimulation, Platelet Activation

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Study Overview

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Study Details

Study overview

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.

Auricular Neuromodulation and Surgical Conditions During Functional Endoscopic Sinus Surgery

Auricular Neuromodulation for FESS

Condition
Functional Endoscopic Sinus Surgery
Intervention / Treatment

-

Contacts and Locations

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ASA 1 and 2
  • * Presenting for elective FESS surgery
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Daniel Katz, MD, PRINCIPAL_INVESTIGATOR, MOUNT SINAI HOSPITAL

Study Record Dates

2025-03-30