Agitation, Emergence, Emergence Delirium
Conditions
Brief summary
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
Interventions
DEVICEBridge Therapy
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.
DEVICESham Therapy
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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-90 2. English Speaking 3. ASA Physical Status between I-IV 4. Undergoing a surgical procedure at HMC 5. Patient answers yes to one of the following below: 1. Do you drink 7 or more alcoholic beverages per week? 2. Do you use (smoke or eat) cannabis (or other recreational drugs) on a weekly basis? 3. Have you felt disoriented, aggressive, angry, or delirious after waking up from a previous surgery? 4. Have you been told by a care provider or friend/family member that you woke up from surgery in the past disoriented, confused, or aggressive/angry? 5. Have you been diagnosed with post-traumatic stress disorder (PTSD)?
Exclusion criteria
1. \<18 years old, \>90 years old 2. Intubated patients 3. Pregnant by HMC lab test 4. Non-English Speaking 5. Has a cardiac pacemaker 6. Hx of bleeding condition 7. Skin issues where the device would be applied, this includes: Dermatitis, Psoriasis vulgaris, skin breakdown, skin integrity compromised. 8. Plan to use dexmedetomidine as part of the anesthetic technique 9. Plan to use sedline for clinical anesthetic management during operating procedure. 10. Patients with previous history of sensitivity to compound benzoin tincture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence agitation | From time of the pre incision time out until 24 hours after admission to the PACU (Post-Anesthesia Care Unit) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue pharmacologic treatment of agitation | From time of the pre incision time out until 24 hours after admission to the PACU (Post-Anesthesia Care Unit) | Incidence of rescue pharmacologic treatment of agitation following general anesthesia. This will be measured by the number of times rescue pharmacological treatment was given. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient State Index | From time of the pre incision time out until 24 hours after admission to the PACU (Post-Anesthesia Care Unit) | 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. |
Outcome results
None listed