Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 主要终点
- Emergence agitation
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English Speaking
- •ASA Physical Status between I-IV
- •Undergoing a surgical procedure at HMC
- •Patient answers "yes" to one of the following below:
- •Do you drink 7 or more alcoholic beverages per week?
- •Do you use (smoke or eat) cannabis (or other recreational drugs) on a weekly basis?
- •Have you felt disoriented, aggressive, angry, or delirious after waking up from a previous surgery?
- •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?
- •Have you been diagnosed with post-traumatic stress disorder (PTSD)?
排除标准
- •<18 years old, >90 years old
- •Intubated patients
- •Pregnant by HMC lab test
- •Non-English Speaking
- •Has a cardiac pacemaker
- •Hx of bleeding condition
- •Skin issues where the device would be applied, this includes: Dermatitis, Psoriasis vulgaris, skin breakdown, skin integrity compromised.
- •Plan to use dexmedetomidine as part of the anesthetic technique
- •Plan to use sedline for clinical anesthetic management during operating procedure.
- •Patients with previous history of sensitivity to compound benzoin tincture.
结局指标
主要结局
Emergence agitation
时间窗: 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).
次要结局
- 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))
研究者
Jeffrey Kirsch
Professor: Anesthesiology and Pain Medicine
University of Washington