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Effects of Stellate Ganglion Block on Delirium and Circadian Rhythm in Geriatric Intensive Care Patients

9 juillet 2026 mis à jour par: Antalya Training and Research Hospital

Effects of Stellate Ganglion Block on Delirium and Circadian Rhythm in Geriatric Intensive Care Patients: A Prospective Randomized Controlled Trial

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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

The primary objective is to determine whether stellate ganglion block reduces delirium incidence in elderly ICU patients. Secondary objectives include evaluating delirium severity, motor subtype distribution, sleep quality, circadian biomarker changes, and ICU and hospital length of stay. This trial aims to provide mechanistic and clinical evidence regarding the potential role of stellate ganglion block in ICU delirium management.

Type d'étude

Interventionnel

Inscription (Estimé)

130

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Nilgun Kavrut Ozturk, professor
  • Numéro de téléphone: +905334196049
  • E-mail: kavrut@yahoo.com

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Turquie (Türkiye)
    • Muratpaşa
      • Antalya, Muratpaşa, Turquie (Türkiye), 07100
        • Antalya Training and Research Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Patients aged 65 years or older expected to remain in the intensive care unit for more than 48 hours
  • RASS score > -4

Exclusion Criteria:

  • 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)
  • Sepsis
  • Allergy to bupivacaine
  • Inability to communicate in Turkish or English
  • Severe hyponatremia
  • Hemodynamic instability

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo Group
Ultrasound-guided intramuscular injection of 2 mL normal saline to the anterolateral cervical region
Procédure: Placebo Injection
Ultrasound-guided sham procedure will be performed, consisting of 2 mL normal saline administered as an intramuscular injection into the anterolateral cervical region, without targeting the stellate ganglion.
Expérimental: Stellate Ganglion Block Group
Ultrasound-guided stellate ganglion block using 5 mL of 0.5% bupivacaine
Procédure: stellate ganglion block with 0.5% bupivacaine
Ultrasound-guided stellate ganglion block will be performed in the supine position using 5 mL of 0.5% bupivacaine administered by an experienced anesthesiologist.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of delirium
Délai: 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.
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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Serum melatonin circadian pattern
Délai: From ICU admission to Day 3 (samples collected at predefined circadian time points: 03:00, 08:00, and 16:00)
Serum melatonin levels will be measured at predefined time points to assess circadian rhythm pattern. Blood samples will be obtained at 03:00, 08:00, and 16:00. Results will be reported in pg/mL. Circadian rhythm assessment will be based on whether the temporal profile of melatonin secretion across these predefined sampling times is consistent with the expected physiological circadian pattern, rather than on isolated measurements alone.
From ICU admission to Day 3 (samples collected at predefined circadian time points: 03:00, 08:00, and 16:00)
Plasma cortisol circadian pattern
Délai: From ICU admission to Day 3, measured three times daily at predefined time points (03:00, 08:00, and 16:00).
Plasma cortisol levels will be measured at predefined time points to assess circadian rhythm pattern. Blood samples will be obtained at 03:00, 08:00, and 16:00. Results will be reported in µg/dL. Circadian rhythm assessment will be based on whether the temporal profile of cortisol secretion across these predefined sampling times is consistent with the expected physiological circadian pattern, rather than on isolated measurements alone.
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)
Délai: From the first diagnosis of delirium until Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
Delirium severity will be assessed using the Delirium Rating Scale-Revised-98 (DRS-R-98), which ranges from 0 to 46. Higher scores indicate more severe delirium. The scale will be applied only in patients diagnosed with delirium according to CAM-ICU.
From the first diagnosis of delirium until Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
Delirium motor subtype distribution
Délai: From the first diagnosis of delirium until Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
Delirium motor subtypes will be classified as hyperactive, hypoactive, or mixed based on the Richmond Agitation-Sedation Scale (RASS) scores in patients diagnosed with delirium using CAM-ICU. Hyperactive delirium will be defined as RASS > 0, hypoactive delirium as RASS < 0, and mixed delirium as fluctuation between positive and negative RASS scores during the assessment period. The outcome will be reported as the distribution of delirium subtypes across study groups.
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)
Délai: From ICU admission to Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), which consists of five items evaluating sleep depth, sleep latency, number of awakenings, ease of returning to sleep, and overall sleep quality. Each item is scored on a visual analog scale from 0 to 100, and the overall score is calculated as the mean of the five items. Higher scores indicate better perceived sleep quality.
From ICU admission to Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
ICU and hospital length of stay
Délai: From hospital admission to discharge home or in-hospital death, whichever occurs first, calculated as total days of hospitalization, assessed up to 60 days.
Hospital length of stay will be defined as the total number of days from hospital admission to hospital discharge.
From hospital admission to discharge home or in-hospital death, whichever occurs first, calculated as total days of hospitalization, assessed up to 60 days.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Antalya Training and Research Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

6 août 2026

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 février 2027

Dates d'inscription aux études

Première soumission

26 mars 2026

Première soumission répondant aux critères de contrôle qualité

27 avril 2026

Première publication (Réel)

30 avril 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juillet 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Cagla

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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