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Not yet recruitingNCT07776496Updated Aug 20, 2026

The Impact of Left Stellate Ganglion Block on Systemic Inflammation and Neuromodulation in CABG Surgery.

An interventional study of Stellate Ganglion Block in Delirium - Postoperative, Inflammation Biomarkers and Stellate Ganglion Block, sponsored by OMAR ABDELAZIZ ABOELFADL. Not yet recruiting. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by OMAR ABDELAZIZ ABOELFADL · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study summary

((82)) patients scheduled to undergo elective CABG by the same surgical team will be allocated randomly by computer-generated random numbers into two equal groups (n= 41).

Study groups:

Group S (Stellate Ganglion Block Group):

Patients will receive an ultrasound-guided Left stellate ganglion block prior to induction of general anesthesia. The block will be performed at the C6 level under strict aseptic precautions using 5 mL of 0.25% bupivacaine. Successful blockade will be confirmed by the appearance of ipsilateral Horner's syndrome.

Group C (Control Group):

Patients will receive standard perioperative care without stellate ganglion block and will undergo the same anesthetic and surgical management protocol as Group S.

Read the detailed description

((82)) patients scheduled to undergo elective CABG by the same surgical team will be allocated randomly by computer-generated random numbers into two equal groups (n= 41).

Study groups:

Group S (Stellate Ganglion Block Group):

Patients will receive an ultrasound-guided Left stellate ganglion block prior to induction of general anesthesia. The block will be performed at the C6 level under strict aseptic precautions using 5 mL of 0.25% bupivacaine. Successful blockade will be confirmed by the appearance of ipsilateral Horner's syndrome.

Group C (Control Group):

Patients will receive standard perioperative care without stellate ganglion block and will undergo the same anesthetic and surgical management protocol as Group S.

Ultrasound guided left stellate ganglion block technique. Sedative dose of IV midazolam (1-2 mg) will be given to the patient in the preanesthetic room under supplemental oxygen nasal cannula 2-4L and electrocardiography (ECG) and pulse oximetry monitoring. Then, under local anesthesia 1% Lidocaine and complete aseptic conditions, arterial line will be inserted after ALLEN test for blood flow into the radial artery of either side for invasive blood pressure (IBP) monitoring and arterial blood gases (ABG) analysis. After that, the patient will be shifted to the operating room (OR) and Pulse oximetry, non-invasive blood pressure (NIBP), invasive blood pressure (IBP) and 5 lead electrocardiography (ECG) will be attached.

The patient will be positioned supine with the head tilted to the right and a thin cushion placed under the lt shoulder to better expose the neck. The skin will be disinfected, and patients will be instructed to avoid speaking, swallowing or making other movements during the procedure, raising their hands if they experience discomfort.

A trained anesthesiologist will use the SonoSite S series ultrasound machine (FUJIFILM SonoSite, Bothell, Washington, USA) to position the HFL38x/13-6 MHz high-frequency linear array probe horizontally at the C6 level. The internal jugular vein, common carotid artery and long neck muscle will be identified through transverse scanning. For patients in the SGB group, a 25-gauge needle will be inserted laterally at the level at C6, with the needle tip reaching the fascia plane of the sympathetic nerve chain, deep to the posterior fascia layer of the carotid sheath and superficial to the fascia covering the long neck muscle. After confirming negative pressure aspiration with no blood return, 5 mL of 0.25% bupivacaine will be injected into the SG. The anesthesiologist will assess the success of the SGB based on the presence of Horner's syndrome, characterized by miosis, ptosis, enophthalmos, nasal congestion, conjunctival congestion, facial redness, absence of sweating and a warm sensation. Control group patients will not receive any block even SHAM block.

General anesthesia technique and intraoperative management. Anesthesia will be induced with fentanyl (1-2 mcg /kg), Propofol (.5-1.5mg/kg) injected slowly and after ensuring adequate depth of anesthesia, rocuronium (0.9 mg/kg) will be given to facilitate endotracheal intubation with a cuffed appropriate size endotracheal tube and after ensuring the correct position and adequacy of ventilation are confirmed with capnography and lung auscultation, the tube is fixed, and the patient is ventilated (Datex-Ohmeda 7100 anesthesia machine) with 6 to 8 ml /kg predicted body weight using volume-controlled mode of ventilation. Respiratory rate is set initially to 12 breaths/ min and adjusted subsequently according to arterial blood gas (ABG) analysis to maintain normocarbia using. Central Venous Catheter, urinary catheter, and nasopharyngeal temperature probe will be inserted under completely aseptic technique. Anesthesia will be maintained with sevoflurane carried by oxygen/air mixture (the ratio is adjusted to maintain SpO2 between 94 % to 98 %), fentanyl (1:5 mic /kg/hr.) and rocuronium (0.3 mg/kg/h). Additional increments of fentanyl (2 mcg/kg) will be administered if mean arterial blood pressure (MAP) or heart rate (HR) rise in response to stressful surgical stimuli greater than 20% above baseline. The following parameters will be continuously monitored during the procedure: Heart rate and rhythm, O2 saturation by pulse oximetry (SpO2), end-tidal CO2, Invasive arterial blood pressure, central venous pressure using (CVP), Core body temperature using esophageal probe, urine output, and neuromuscular blockade using peripheral nerve stimulation.

Cardiopulmonary Bypass

  • Standardized CPB protocol for all patients:
  • Membrane oxygenator, arterial line filter.
  • Priming: saline 1000-1500 mL with 5000 IU heparin.
  • Anticoagulation: Heparin 300-400 IU/kg to maintain ACT >480 seconds.
  • Flow rate: 2.2-2.4 L/min/m².
  • Temperature: Moderate hypothermia (32-34°C) or normothermia (36-37°C) per surgeon preference (will be recorded and analyzed).
  • Myocardial protection: Antegrade cold blood cardioplegia or Custodial® per institutional standard.

During CPB:

  • Propofol infusion continued as needed for sedation.
  • Neuromuscular blockade maintained.
02

Conditions studied

  • Delirium - Postoperative
  • Inflammation Biomarkers
  • Stellate Ganglion Block
  • CABG

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Keywords

  • postoperative Delirium
  • stellate ganglion block
  • SGB
  • IL6
  • Inflammatory biomarkers
03

In context

Emergence Delirium

752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

This study's planned enrollment of 81 is below the median of 120 across 466 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

This is the only study on the registry with OMAR ABDELAZIZ ABOELFADL as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. All elderly (≥65 years) patients of both genders, as according to the World Health Organization, the chronologic age of 65 years was accepted by most developed countries in the world as a definition of "elderly" or older person. Patients scheduled for elective cardiac surgery under general anesthesia.14
  2. (ASA) physical status class II or III.
  3. Patients will be stratified according to their baseline surgical risk utilizing the EuroSCORE II tool >4%15.
  4. American Society of Anesthesiologists (ASA) physical status class II or III.

Exclusion criteria

Exclusion Criteria:

  1. Pre-existing dementia or significant cognitive impairment.
  2. History of stroke or cerebrovascular disease.
  3. to SGB (e.g., coagulopathy, local infection, or anatomical abnormalities).
  4. Preoperative use of antipsychotics or antidepressants.
  5. Sinus bradycardia \<50bpm \&complete heart block
  6. >35
  7. Redo or emergency surgery.
  8. On preoperative mechanical ventilation and long sedation time.
  9. Low EF patients \<35%.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
81 participants (estimated)

Study arms

  • Experimental
    stellate ganglion block

    Group S (Stellate Ganglion Block Group): Patients will receive an ultrasound-guided Left stellate ganglion block prior to induction of general anesthesia. The block will be performed at the C6 level under strict aseptic precautions using 5 mL of 0.25% bupivacaine. Successful blockade will be confirmed by the appearance of ipsilateral Horner's syndrome.

    Procedure: Stellate Ganglion Block

  • No intervention
    control

    Group C (Control Group): Patients will receive standard perioperative care without stellate ganglion block and will undergo the same anesthetic and surgical management protocol as Group S.

Interventions

  • ProcedureStellate Ganglion Block

    ultrasound guided left stellate ganglion block in patients undergoing CABG surgery to compare with control group which not receive any block even SHAM block and show its effect on reducing inflammatory biomarkers especially il6 and its effect in reducing postoperative delirium

06

What researchers measure

Primary outcomes

  1. Interleukin 6 (IL-6) level in pg/ml change from baseline

    Time frame: 0 (baseline) and 6 hours after cardiopulmonary bypass

Secondary outcomes

  1. 1. Incidence of postoperative delirium

    A trained nurse will evaluate the patients two times (06:00-08:00 and 18:00-20:00). The confusion assessment method CAM-ICU. This method includes the following four evaluation indicators: (1) changes in mental state or fluctuations in consciousness levels during acute attacks; (2) lack of concentration; (3) confused thinking and (4) changes in level of consciousness. If both features 1 and 2 are positive and at least one of the features 3 or 4 is positive, the diagnosis is delirium. Subtypes of delirium are classified according to RASS score: hyperactive type (RASS \>0), hypoactive type (RASS\<0), and mixed type (alternating between hypoactive and hyperactive types).

    Time frame: day 0 to 3 days after successful extubation

  2. 2. Delirium severity will be assessed using the Delirium Rating Scale-Revised-98.

    This scale features 16 items rated by clinicians and is divided into two sections: one with 13 severity items and another with three diagnostic items. Each severity item is scored from 0 to 3 points, while the diagnostic items are rated from 0 to 2 or 3 points.

    Time frame: day 0 to 3 days after successful extubation

  3. 3. CRP in mg/L, neutrophil to lymphocyte ratio (NLR) and Platelet to white cell ratio (PWR).

    Time frame: day 0 (baseline) to day 3

  4. 4. Creatinine baseline level in mg/dl, 24 h postoperatively, 48 h postoperatively, and the urine output was recorded on the first and second postoperative days.

    Time frame: 0 (baseline) to 48 hours postoperative

  5. 6. Total intraoperative opioid consumption

    Time frame: 0 hour From induction of anesthesia to 5 hours after induction of anesthesia

  6. 7. Postoperative opioid consumption (MME)

    Time frame: at 2, 6, 12, 24, and 48 hours post-extubation.

  7. 8. ICU length of stay

    Time frame: From icu admission to 10 days after icu admission

  8. 9. Hospital length of stay (day from surgery to hospital discharge).

    Time frame: From hospital admission to 10 days postoperative

  9. 10. Complications during and after the operation were monitored until the patient was discharged.

    including pleural effusion, pericardial effusion, arrhythmia, organ failure, and surgical incision infections.

    Time frame: From 0 hour (inter-operative) to 72 hours (postoperative)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Mar 2028, 15 months later.

Of 186 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 15 months is below that.

Counting every sponsor, half of 186 studies reached it within 19 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2026
First posted
Aug 20, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Mar 1, 2028
CompletionEst.
Aug 1, 2028
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07776496
Lead sponsor
OMAR ABDELAZIZ ABOELFADL
Responsible party
OMAR ABDELAZIZ ABOELFADL (assistant lecturer of anaesthesiology, intensive care and pain management, faculty of medicine, assiut university, Assiut University) — Sponsor-investigator
First posted
Aug 20, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Aug 20, 2026

Study contacts

omar abulfadl abulfadl, assistant lecturer
Contact
omarabulfadl1@gmail.com
+201069909234

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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