Effects of Stellate Ganglion Block on Delirium and Circadian Rhythm in Geriatric Intensive Care Patients
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Nilgun Kavrut Ozturk, professor
- Telefonnummer: +905334196049
- E-post: kavrut@yahoo.com
Studer Kontakt Backup
- Navn: Cagla Doganci, Resident
- Telefonnummer: +905416480782
- E-post: cagladogancii@gmail.com
Studiesteder
-
-
Muratpaşa
-
Antalya, Muratpaşa, Tyrkia (Türkiye), 07100
- Antalya Training and Research Hospital
-
Ta kontakt med:
- Cagla Doganci, Resident
- Telefonnummer: +905416480782
- E-post: cagladogancii@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo Group
Ultrasound-guided intramuscular injection of 2 mL normal saline to the anterolateral cervical region
|
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.
|
|
Eksperimentell: Stellate Ganglion Block Group
Ultrasound-guided stellate ganglion block using 5 mL of 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of delirium
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum melatonin circadian pattern
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Cagla
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .