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Withdrew study equipment issue.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group Stimulation of Vagus Nerve | Active Comparator | Stimulation of the vagus nerve with nerve stimulator placed on neck |
|
| Sham Placebo Group No Stimulation to Vagus Nerve | Placebo Comparator | Nerve stimulator placed on neck but not activated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus nerve stimulator | Device | Vagus nerve stimulator placed on neck and activated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aim 1: To determine if administering tcVNS enhances recovery from anesthesia | Time to a Patient State Indexâ„¢ (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. | 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. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyson Engle, MD | Northwestern Univesity | Principal Investigator |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Randomized controlled trial
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Participant and outcomes assessor will not know which treatment arm the subject has been assigned to during the study.
| Placebo comparator sham | Device | Vagus nerve stimulator placed on neck and not activated |
|
| 1 month after surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |