A Prospective, Randomized, Single-Blinded, Crossover Clinical Trial Evaluating the Use of Noninvasive Transcutaneous Vagal Nerve Stimulation (tcVNS) for Neuromodulating the Conscious State
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Aim 1: To determine if administering tcVNS enhances recovery from anesthesia
研究概览
简要总结
The purpose of this study is to examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) (Gammacore Sapphire Device) can help restore consciousness in patients in the Operating Room and Post Anesthesia Care Unit (PACU). To examine whether tcVNS administered in the PACU can help reduce delirium and depression post-surgery, speeding up cognitive recovery from anesthesia, and finally determine if tcVNS can expedite discharge from the PACU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and outcomes assessor will not know which treatment arm the subject has been assigned to during the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 18 years of age
- •Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
- •Mini-Mental State Examination (MMSE) score ≥ 15-accept mild
- •Ability to use a keyboard
- •Able to understand and communicate in English
- •Be able to consent independently
- •Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study.
- •Must not be involved in any other research intervention study testing neurobehavioral functioning
- •Good internet connectivity and ability to use computer, smart phone or good telephone connectivity (follow up)
排除标准
- •Age < 18 years of age
- •History of vagotomy (cutting the vagus nerve)
- •History of bradycardia, heart block, prolonged QT syndrome, brugada syndrome, heart failure with ejection fraction less than 35% and/or New York Heart Association symptoms
- •MMSE < 15
- •History of seizure disorder or intracranial hemorrhage
- •Patients with carotid stenosis
- •Patients with aneurysms
- •Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability
- •Pregnancy, breastfeeding
- •Active addiction history
- •ECG adhesive allergy
- •Severe aphasia, preventing subject from understanding the protocol and giving written consent
- •Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- •Patients with metallic device such as a stent, bone plate or bone screw implanted at or near their neck
- •Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- •Patients with metallic device such as a stent, bone plate or bone screw implanted at or near their neck
- •Patients who are using another device at the same time (e.g., transcutaneous electrical nerve stimulation (TENS) Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).
研究组 & 干预措施
Treatment Group Stimulation of Vagus Nerve
Stimulation of the vagus nerve with nerve stimulator placed on neck
干预措施: Vagus nerve stimulator (Device)
Sham Placebo Group No Stimulation to Vagus Nerve
Nerve stimulator placed on neck but not activated.
干预措施: Placebo comparator sham (Device)
结局指标
主要结局
Aim 1: To determine if administering tcVNS enhances recovery from anesthesia
时间窗: 60 minutes
Time to a Patient State Index™ (PSi, Sedline Sedation Monitor, Massimo, Inc, Irvine, CA) score of 85.The PSi is a quantitative score derived from 4 channel EEG monitoring of the frontal and prefrontal cortex for assessing level of consciousness during sedation and general anesthesia. The score ranges from 0 (EEG suppression) to 100 (fully awake). A PSi range of 25-50 indicates optimal hypnotic state for general anesthesia.
To determine if administering tcVNS improves Richmond Agitation-Sedation Scale (RASS) scores after anesthesia
时间窗: 60 minutes
RASS Score on arrival to the PACU then 10, 15, 30, 45 and 60 min later.The Richmond Agitation-Sedation Scale (RASS) is a standardized instrument to assess arousal, cognition, and sustainability to stepped progression of stimuli. The patient is first observed. If alert a score between 1 to 4 is assigned based on their cognitive state. If the patient is not alert, the patient's name is loudly spoken and they are instructed to open their eyes and look at the speaker. This is repeated once if necessary. If there is eye opening and eye contact for \> 10 seconds, a score of -1 is assigned. If not sustained for 10 secs then a score of -2 is assigned, and so forth.
次要结局
- To determine if tcVNS can improve conscious cognitive control in post-surgical patients.(1 month after surgery)