NCT07776496

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Dec 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

July 30, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

postoperative Deliriumstellate ganglion blockSGBIL6Inflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

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

    0 (baseline) and 6 hours after cardiopulmonary bypass

Secondary Outcomes (9)

  • 1. Incidence of postoperative delirium

    day 0 to 3 days after successful extubation

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

    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

  • +4 more secondary outcomes

Study Arms (2)

stellate ganglion block

EXPERIMENTAL

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

control

NO INTERVENTION

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

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

stellate ganglion block

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • American Society of Anesthesiologists (ASA) physical status class II or III.
  • Patients will be stratified according to their baseline surgical risk utilizing the EuroSCORE II tool \>4%15.
  • American Society of Anesthesiologists (ASA) physical status class II or III.

You may not qualify if:

  • Pre-existing dementia or significant cognitive impairment.
  • History of stroke or cerebrovascular disease.
  • Contraindications to SGB (e.g., coagulopathy, local infection, or anatomical abnormalities).
  • Preoperative use of antipsychotics or antidepressants.
  • Sinus bradycardia \<50bpm \&complete heart block
  • BMI\>35
  • Redo or emergency surgery.
  • On preoperative mechanical ventilation and long sedation time.
  • Low EF patients \<35%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

omar abulfadl abulfadl, assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer of anaesthesiology, intensive care and pain management, faculty of medicine, assiut university

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 20, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

August 20, 2026

Record last verified: 2026-08