Stellate Ganglion BlockNCT07558642
Effects of Stellate Ganglion Block on Delirium and Circadian Rhythm in Geriatric Intensive Care Patients
A study testing stellate ganglion block with 0.5% bupivacaine in people with Stellate Ganglion Block, run by Antalya Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Stellate Ganglion Block
- What is being tested?
- stellate ganglion block with 0.5% bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 Aug 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65 years or older expected to remain in the intensive care unit for more than 48 hours
- RASS score > -4
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Antalya Training and Research Hospital
Antalya, Muratpaşa, 07100
Cagla Doganci, Resident, +905416480782, cagladogancii@gmail.com
- Recruiting
Antalya Training and Research Hospital
Antalya, Muratpaşa, 07100
About this study
Official title: 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
Read the detailed description
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.
- Conditions
- Stellate Ganglion Block
- Being tested
- stellate ganglion block with 0.5% bupivacaine, Placebo Injection
- Keywords
- Stellate Ganglion Block, Delirium, Intensive Care Unit, Circadian Rhythm, Melatonin, Cortisol
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion block with 0.5% bupivacaineProcedure or surgery
Ultrasound-guided stellate ganglion block will be performed in the supine position using 5 mL of 0.5% bupivacaine administered by an experienced anesthesiologist.
Placebo InjectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Ultrasound-guided intramuscular injection of 2 mL normal saline to the anterolateral cervical region Receives: Procedure: Placebo Injection |
| Stellate Ganglion Block Group | Experimental | Ultrasound-guided stellate ganglion block using 5 mL of 0.5% bupivacaine Receives: Procedure: stellate ganglion block with 0.5% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From ICU admission to Day 3 (samples collected at predefined circadian time points: 03:00, 08:00, and 16:00)
Plasma cortisol circadian pattern
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.
Measured: 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)
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.
Measured: From the first diagnosis of delirium until Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
Delirium motor subtype distribution
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.
Measured: 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)
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.
Measured: From ICU admission to Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
ICU and hospital length of stay
Hospital length of stay will be defined as the total number of days from hospital admission to hospital discharge.
Measured: From hospital admission to discharge home or in-hospital death, whichever occurs first, calculated as total days of hospitalization, assessed up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start6 Aug 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558642
- Sponsor's protocol ID
- Cagla
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stellate Ganglion Block on Delirium and Circadian Rhythm in Geriatric Intensive Care Patients: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07558642
- Acronym / sponsor ID
- Cagla
- Conditions
- Stellate Ganglion Block
- Keywords
- Stellate Ganglion Block, Delirium, Intensive Care Unit, Circadian Rhythm, Melatonin, Cortisol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Procedure: Placebo InjectionUltrasound-guided intramuscular injection of 2 mL normal saline to the anterolateral cervical region |
| Stellate Ganglion Block Group | Experimental | Procedure: stellate ganglion block with 0.5% bupivacaineUltrasound-guided stellate ganglion block using 5 mL of 0.5% bupivacaine |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients aged 65 years or older expected to remain in the intensive care unit for more than 48 hours
- RASS score > -4
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stellate ganglion block with 0.5% bupivacaineUltrasound-guided stellate ganglion block will be performed in the supine position using 5 mL of 0.5% bupivacaine administered by an experienced anesthesiologist. | Procedure or surgery | Stellate Ganglion Block Group |
| Placebo InjectionUltrasound-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. | Procedure or surgery | Placebo Group |
Primary outcome
Incidence of delirium
Time frame: 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.
6 secondary outcomes
Serum melatonin circadian pattern
Time frame: From ICU admission to Day 3 (samples collected at predefined circadian time points: 03:00, 08:00, and 16:00)
Plasma cortisol circadian pattern
Time frame: 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)
Time frame: From the first diagnosis of delirium until Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
Delirium motor subtype distribution
Time frame: 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)
Time frame: From ICU admission to Day 7 of ICU stay or ICU discharge, whichever occurs first, assessed daily.
ICU and hospital length of stay
Time frame: From hospital admission to discharge home or in-hospital death, whichever occurs first, calculated as total days of hospitalization, assessed up to 60 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stellate ganglion block with 0.5% bupivacaine in people with Stellate Ganglion Block, run by Antalya Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilgun Kavrut Ozturk, professor (+905334196049, kavrut@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.