Effects of Stellate Ganglion Block on Delirium and Circadian Rhythm in Geriatric Intensive Care Patients: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
Delirium is a common complication in elderly intensive care unit (ICU) patients and is associated with poor clinical outcomes. Circadian rhythm disruption is considered an important contributing factor in delirium development. Stellate ganglion block (SGB) may modulate autonomic nervous system activity and improve circadian rhythm regulation.
This prospective randomized placebo-controlled trial aims to evaluate the effects of ultrasound-guided stellate ganglion block on delirium incidence and circadian rhythm in ICU patients aged 65 years and older. Delirium will be assessed using validated clinical scales, and circadian rhythm will be evaluated through serial measurements of serum melatonin and plasma cortisol levels
详细描述
Delirium is a common and serious complication among elderly intensive care unit (ICU) patients and is associated with increased morbidity, mortality, prolonged hospitalization, and poor long-term outcomes. Although the pathophysiology of delirium is multifactorial, growing evidence suggests that disruption of circadian rhythm and autonomic nervous system imbalance play an important role in its development. Current pharmacological and non-pharmacological treatment strategies remain limited, highlighting the need for novel preventive and therapeutic approaches.
Stellate ganglion block (SGB) is an ultrasound-guided autonomic modulation technique that has been shown to influence sympathetic activity, sleep regulation, and circadian rhythm. However, its potential role in reducing ICU delirium and modulating circadian biomarkers has not been clearly established.
This study is designed as a prospective, randomized, placebo-controlled to investigate the effects of ultrasound-guided stellate ganglion block on delirium and circadian rhythm in geriatric ICU patients. Eligible patients aged 65 years and older will be randomized in a 1:1 ratio to receive either stellate ganglion block with 0.5% bupivacaine or placebo saline injection. Randomization will be computer-generated, and outcome assessors will be blinded to group allocation.
Delirium will be assessed twice daily for seven days using validated clinical tools, including the Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the ICU (CAM-ICU). Delirium severity will be evaluated using the Delirium Rating Scale-Revised-98, and motor subtypes (hyperactive, hypoactive, mixed) will be categorized according to RASS scores. Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire.
To evaluate circadian rhythm, serum melatonin and plasma cortisol levels will be measured at predefined circadian time points during the first three days following ICU admission. The study combines objective biomarker assessment with standardized delirium evaluation to explore potential mechanistic pathways linking autonomic modulation and neurocognitive outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to group allocation. The anesthesiologist performing the procedure will assess block success based on the presence of Horner syndrome and will not participate in delirium assessments, sleep evaluations, biomarker measurements, or data analysis. All clinical outcome assessments will be performed by independent blinded investigators.
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years or older expected to remain in the intensive care unit for more than 48 hours
- •RASS score > -4
排除标准
- •History of neurodegenerative disease (e.g., Alzheimer's disease, dementia, vascular dementia)
- •Uncontrolled psychiatric disorders
- •Alcohol use disorder and/or substance abuse
- •History of traumatic brain injury or ischemic/hemorrhagic cerebrovascular event
- •Severe hearing and/or visual impairment
- •Benzodiazepine use
- •Renal failure (Acute Kidney Injury stage 2-3) and/or liver failure
- •Beta-blocker use
- •Contraindications to stellate ganglion block (e.g., coagulopathy, glaucoma, recent myocardial infarction)
- •Allergy to bupivacaine
- •Inability to communicate in Turkish or English
- •Severe hyponatremia
- •Hemodynamic instability
研究组 & 干预措施
Stellate Ganglion Block Group
Ultrasound-guided stellate ganglion block using 5 mL of 0.5% bupivacaine
干预措施: stellate ganglion block with 0.5% bupivacaine (Procedure)
Placebo Group
Ultrasound-guided intramuscular injection of 2 mL normal saline to the anterolateral cervical region
干预措施: Placebo Injection (Procedure)
结局指标
主要结局
Incidence of delirium
时间窗: From randomization until Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed twice daily (06:00-08:00 and 20:00-22:00).
Delirium incidence will be assessed in patients receiving stellate ganglion block and in patients not receiving stellate ganglion block using a standardized two-step evaluation process. Patients will first be assessed with the Richmond Agitation-Sedation Scale (RASS), which ranges from -5 (unarousable) to +4 (combative). Only patients with a RASS score greater than -4 will undergo delirium assessment using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), a validated diagnostic instrument for delirium. Delirium will be recorded as present or absent according to CAM-ICU findings. Higher RASS scores indicate increased agitation, whereas lower scores indicate deeper sedation. Minimum and maximum scores are not applicable to CAM-ICU because it is used as a binary diagnostic tool rather than a numerical scale.
次要结局
- Serum melatonin circadian pattern(From ICU admission to Day 3 (samples collected at predefined circadian time points: 03:00, 08:00, and 16:00))
- Plasma cortisol circadian pattern(From ICU admission to Day 3, measured three times daily at predefined time points (03:00, 08:00, and 16:00).)
- Delirium severity (Delirium Rating Scale-Revised-98 score)(From the first diagnosis of delirium until Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.)
- Delirium motor subtype distribution(From the first diagnosis of delirium until Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.)
- Sleep quality (Richards-Campbell Sleep Questionnaire score)(From ICU admission to Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.)
- ICU and hospital length of stay(From hospital admission to discharge home or in-hospital death, whichever occurs first, calculated as total days of hospitalization, assessed up to 60 days.)