An interventional study of Bridge Therapy and Sham Therapy in Emergence Delirium and Agitation, Emergence, sponsored by University of Washington. Withdrawn. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
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
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
Browse Emergence Delirium studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Subjects receive the Bridge therapy
Device: Bridge Therapy
Subjects receive a placebo or sham therapy
Device: Sham 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.
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.
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)
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)
Patient State Index
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.
Time frame: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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