Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

Not Applicable

Withdrawn

• Conditions: Emergence Delirium; Agitation, Emergence
• Interventions: Device: Bridge Therapy; Device: Sham Therapy

• Registration Number: NCT06387953
• Lead Sponsor: University of Washington

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-30
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-29
• Study Start: 2024-08-27
• Primary Completion: 2024-08-27
• Study Completion: 2024-08-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 50

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)?

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bridge Therapy	Bridge Therapy	Subjects receive the Bridge therapy
Placebo	Sham Therapy	Subjects receive a placebo or sham therapy

Primary Outcome Measures

Name	Time	Method
Emergence agitation	time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)	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).

Secondary Outcome Measures

Name	Time	Method
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.