Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

University of Washington

Status: Withdrawn

Conditions: Agitation, Emergence; Emergence Delirium

Treatments: Device: Sham Therapy; Device: Bridge Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06387953

STUDY00019480

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Bridge Therapy

Active Comparator group

Description:

Subjects receive the Bridge therapy

Treatment:

Device: Bridge Therapy

Placebo

Placebo Comparator group

Description:

Subjects receive a placebo or sham therapy

Treatment:

Device: Sham Therapy