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

NCT07558642 | Not Yet Recruiting DMC

• 1 other identifier: Cagla
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Stellate Ganglion Block

Keywords

Stellate Ganglion Block; Delirium; Intensive Care Unit; Circadian Rhythm; Melatonin; Cortisol

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium

  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).

Secondary Outcomes (6)

• 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.

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Ultrasound-guided intramuscular injection of 2 mL normal saline to the anterolateral cervical region

Procedure: Placebo Injection

Stellate Ganglion Block Group

EXPERIMENTAL

Ultrasound-guided stellate ganglion block using 5 mL of 0.5% bupivacaine

Procedure: stellate ganglion block with 0.5% bupivacaine

Interventions

stellate ganglion block with 0.5% bupivacaine PROCEDURE

Ultrasound-guided stellate ganglion block will be performed in the supine position using 5 mL of 0.5% bupivacaine administered by an experienced anesthesiologist.

Stellate Ganglion Block Group

Placebo Injection PROCEDURE

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.

Placebo Group

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (2)

Antalya Training and Research Hospital

Antalya, Muratpaşa, 07100, Turkey (Türkiye)

Location

Antalya Training and Research Hospital

Antalya, Muratpaşa, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delirium

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Nilgun Kavrut Ozturk, professor

CONTACT

+905334196049; kavrut@yahoo.com

Cagla doğanci, Resident

CONTACT

+905416480782; cagladogancii@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

TU (2)