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The sponsor of the study and the University of Washington were not able to come to an agreement on the intellectual property provisions. Therefore, this study will not be carried out.
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This is a randomized, prospective, double-blinded (patient and outcome-assessor) trial. Our goal is to assess efficacy of Bridge Therapy (versus sham bridge therapy) to prevent emergence agitation following general anesthesia.
Primary Objective: Activation of Bridge Therapy from the time of the pre incision "time out" until 24 hours after admission to the PACU (Post Anesthesia Care Unit) is associated with reduced frequency and intensity of emergence agitation.
Secondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation.
Tertiary Objective: Activation of Bridge Therapy during a stable anesthetic state is associated with a reduced Patient State Index as measured on Sedline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridge Therapy | Active Comparator | Subjects receive the Bridge therapy |
|
| Placebo | Placebo Comparator | Subjects receive a placebo or sham therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bridge Therapy | Device | After the patient has been intubated in the operating room - the Bridge device intervention will be applied to the subject's ear by a trained study team member. At the time of the pre-incision pause, Initiation of the intervention (Bridge therapy) will begin and will be continued throughout the surgery. The intervention will continue for 24 hours after extubation. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergence agitation | Frequency of emergence agitation following general anesthesia will be collected every 15 minutes in the PACU. Once discharged from the PACU this will be measured every 12 hours. | From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit) |
| Emergence agitation | Intensity of emergence agitation following general anesthesia will be measured by the Riker Sedation Agitation Scale (RSAS). The maximum score is 7, the minimum score is 1. A high scores means a worse outcome (higher agitation). | time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit) |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue pharmacologic treatment of agitation | Incidence of rescue pharmacologic treatment of agitation following general anesthesia. This will be measured by the number of times rescue pharmacological treatment was given. | From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient State Index | Patient State Index or PSI is a clinically validated measure of the effect of anesthesia and sedation. PSI is measured on a Sedline Sedation Monitor. PSI values range from 0 (total cortical silence) to 100 (awake state), and 25-50 indicates the optimal hypnotic state for surgical anesthesia. | From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit) |
Inclusion Criteria:
Age 18-90
English Speaking
ASA Physical Status between I-IV
Undergoing a surgical procedure at HMC
Patient answers "yes" to one of the following below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kirsch, MD | University of Washington | Principal Investigator |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000093142 | Bridge Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Sham Therapy | Device | After the patient has been intubated in the operating room - the Bridge device intervention will be applied to the subject's ear by a trained study team member. At the time of the pre-incision pause, Initiation of the intervention (Sham therapy) will begin and will be continued throughout the surgery. The intervention will continue for 24 hours after extubation. |
|
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |