Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery. The study will also evaluate whether tcVNS speeds cognitive recovery from emergence of anesthesia and surgery.
Eligibility criteria
Qualifiers
Aged > 18 years of age
Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild
Ability to use a keyboard
Disqualifiers
Age < 18 years of age
History of vagotomy (cutting the vagus nerve)
History of bradycardia, heart block, prolonged QT syndrome, brugada syndrome, heart failure with ejection fraction less than 35% and/or New York Heart Association symptoms
MoCA < 18
Trial design
Treatments tested in this trial
- Transcutaneous vagal nerve stimulation
- Sham (No Treatment)
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
1Northwestern University Feinberg School of Medicine60611, ChicagoIllinois, United States
Sponsors and collaborators
Northwestern University
Lead sponsor
Source ClinicalTrials.gov