NCT07610655招募中不适用
Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery. The study will also evaluate whether tcVNS speeds cognitive recovery from emergence of anesthesia and surgery.
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
- Single (Participant)
盲法说明
Participant will be blinded to which group they were randomized.
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
- •Montreal Cognitive Assessment (MoCA) score ≥ 18 - 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
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
- •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 will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.
研究者
Charles Hogue
James E. Eckenhoff Professor, Chair, Department of Anesthesiology
Northwestern University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.TMDNCT07288411Arpana Church10
尚未招募
不适用
Feasibility and Expansion Trial of Transcutaneous Vagus Nerve Stimulation (tVNS) for Immune-Related Fatigue in Patients Receiving Immune Checkpoint InhibitorsCancer-related FatigueNCT07529431University of Vermont Medical Center13
招募中
不适用
Vagus Nerve Stimulation Effect in Frozen Shoulder TreatmentNCT07368751Istanbul University - Cerrahpasa40
已完成
不适用
taVNS During Exercise and Recovery in Chronic Spinal Cord InjurySpinal Cord Injury, ChronicNCT07524491University of the Balearic Islands35
尚未招募
不适用
Effects of taVNS on Postoperative Pain in Complex Spinal SurgeryNCT07330973Second Affiliated Hospital, School of Medicine, Zhejiang University98