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

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

((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.

Study Overview

• Status: Not yet recruiting
• Conditions: CABG; Stellate Ganglion Block; Inflammation Biomarkers; Delirium - Postoperative
• Intervention / Treatment: Procedure: Stellate Ganglion Block

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.

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: omar abulfadl abulfadl, assistant lecturer; Phone Number: +201069909234; Email: omarabulfadl1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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. American Society of Anesthesiologists (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:

1. Pre-existing dementia or significant cognitive impairment.
2. History of stroke or cerebrovascular disease.
3. Contraindications 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. BMI>35
7. Redo or emergency surgery.
8. On preoperative mechanical ventilation and long sedation time.
9. Low EF patients <35%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Interleukin 6 (IL-6) level in pg/ml change from baseline	0 (baseline) and 6 hours after cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	day 0 to 3 days after successful extubation
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.	day 0 to 3 days after successful extubation
3. CRP in mg/L, neutrophil to lymphocyte ratio (NLR) and Platelet to white cell ratio (PWR).		day 0 (baseline) to day 3
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.		0 (baseline) to 48 hours postoperative
6. Total intraoperative opioid consumption		0 hour From induction of anesthesia to 5 hours after induction of anesthesia
7. Postoperative opioid consumption (MME)		at 2, 6, 12, 24, and 48 hours post-extubation.
8. ICU length of stay		From icu admission to 10 days after icu admission
9. Hospital length of stay (day from surgery to hospital discharge).		From hospital admission to 10 days postoperative
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.	From 0 hour (inter-operative) to 72 hours (postoperative)

Collaborators and Investigators

• Sponsor: OMAR ABDELAZIZ ABOELFADL

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 20, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: stellate ganglion block; SGB; IL6; Inflammatory biomarkers; postoperative Delirium
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: Lt SGB in CABG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No