An interventional study of Vagus nerve stimulator and Placebo comparator sham in Anesthesia, Delirium and Depression, sponsored by Northwestern University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
The purpose of this study is to examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) (Gammacore Sapphire Device) can help restore consciousness in patients in the Operating Room and Post Anesthesia Care Unit (PACU). To examine whether tcVNS administered in the PACU can help reduce delirium and depression post-surgery, speeding up cognitive recovery from anesthesia, and finally determine if tcVNS can expedite discharge from the PACU.
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Exclusion Criteria:
Stimulation of the vagus nerve with nerve stimulator placed on neck
Device: Vagus nerve stimulator
Nerve stimulator placed on neck but not activated.
Device: Placebo comparator sham
Vagus nerve stimulator placed on neck and activated
Vagus nerve stimulator placed on neck and not activated
Aim 1: To determine if administering tcVNS enhances recovery from anesthesia
Time to a Patient State Index™ (PSi, Sedline Sedation Monitor, Massimo, Inc, Irvine, CA) score of 85.The PSi is a quantitative score derived from 4 channel EEG monitoring of the frontal and prefrontal cortex for assessing level of consciousness during sedation and general anesthesia. The score ranges from 0 (EEG suppression) to 100 (fully awake). A PSi range of 25-50 indicates optimal hypnotic state for general anesthesia.
Time frame: 60 minutes
To determine if administering tcVNS improves Richmond Agitation-Sedation Scale (RASS) scores after anesthesia
RASS Score on arrival to the PACU then 10, 15, 30, 45 and 60 min later.The Richmond Agitation-Sedation Scale (RASS) is a standardized instrument to assess arousal, cognition, and sustainability to stepped progression of stimuli. The patient is first observed. If alert a score between 1 to 4 is assigned based on their cognitive state. If the patient is not alert, the patient's name is loudly spoken and they are instructed to open their eyes and look at the speaker. This is repeated once if necessary. If there is eye opening and eye contact for \> 10 seconds, a score of -1 is assigned. If not sustained for 10 secs then a score of -2 is assigned, and so forth.
Time frame: 60 minutes
To determine if tcVNS can improve conscious cognitive control in post-surgical patients.
Targeted tcVNS compared to sham tcVNS will reduce PACU and hospital ward delirium and post-surgical depression. The investigators will test this hypothesis by PACU and in-hospital evaluations for delirium and in-hospital measurement of depression prior to discharge and at a one-month virtual follow-up evaluation.
Time frame: 1 month after surgery
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Northwestern University