Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

University of Washington

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Emergence Delirium Agitation, Emergence

Interventions

Bridge TherapyDEVICE

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.

Sham TherapyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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 frame: time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)

Secondary Outcomes

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.

Time frame: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)

Data from ClinicalTrials.gov

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