Clinical trial NCT06387953: Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy
Official title: Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Emergence Delirium
Agitation, Emergence
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Emergence agitation
timeFrame: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
measure: Emergence agitation
timeFrame: time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
Secondary outcomes:
measure: Rescue pharmacologic treatment of agitation
timeFrame: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
Other outcomes:
measure: Patient State Index
timeFrame: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
Locations:
Study officials:
affiliation: University of Washington
name: Jeffrey Kirsch, MD
role: PRINCIPAL_INVESTIGATOR
References: