Effect of Preoperative Ultrasound-Guided Stellate Ganglion Block on Postoperative Delirium in Older Adults Undergoing Elective Peripheral Endovascular Intervention

NCT07848113 | Not Yet Recruiting

• 1 other identifier: Postoperative Delirium
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial will evaluate whether preoperative ultrasound-guided stellate ganglion block reduces the incidence of postoperative delirium in adults aged 60 years or older undergoing elective peripheral endovascular interventions. Participants will be randomly allocated in a 1:1 ratio to receive either a right-sided ultrasound-guided stellate ganglion block at the C6 level with 5 mL of 0.375% ropivacaine or a control group. Postoperative delirium will be assessed twice daily during the first 3 postoperative days using the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium (3D-CAM).

Conditions

Postoperative Delirium (POD); Peripheral Arterial Disease

Keywords

Postoperative delirium; stellate ganglion block

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of postoperative delirium

  .Postoperative delirium will be assessed twice daily during the first 3 postoperative days using the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium (3D-CAM). A participant will be considered to have developed postoperative delirium if at least one postoperative delirium assessment is positive during the first 3 postoperative days.

  postoperative 24 hours , 48 hours , 72 hours.

Secondary Outcomes (5)

• Delirium severity

  postoperative 24 hours , 48 hours , 72 hours , among participants diagnosed with postoperative delirium

• Duration of postoperative delirium

  postoperative 24 hours , 48 hours , 72 hours.

• Postoperative pain intensity

  Immediate postoperative period 2 hours 6 hours 12 hours 24 hours

• Total postoperative opioid consumption

  postoperative 24 hours , 48 hours , 72 hours.

• Safety and adverse events

  postoperative 24 hours , 48 hours , 72 hours.

Study Arms (2)

Ultrasound-Guided Stellate Ganglion Block

EXPERIMENTAL

Participants will receive a right-sided ultrasound-guided stellate ganglion block at the C6 level approximately 30 minutes before surgery. Under sterile conditions and real-time ultrasound guidance, a 22-gauge needle will be advanced to the prevertebral fascia. After negative aspiration, 5 mL of 0.375% ropivacaine will be injected. Successful sympathetic blockade will be assessed by development of Horner's syndrome and/or a relative increase in ipsilateral skin temperature of ≥1.5°C within 15 minutes after injection

Drug: ropivacaine

control group

NO INTERVENTION

the participants will receive standard perioperative care and regional anesthesia according to the study protocol, but no stellate ganglion block or sham procedure will be performed

Interventions

ropivacaine DRUG

5 mL of 0.375% ropivacaine administered during ultrasound-guided right stellate ganglion block at the C6 level approximately 30 minutes before surgery.

Ultrasound-Guided Stellate Ganglion Block

Eligibility Criteria

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

You may qualify if:

• Age ≥65 years.
• Scheduled for elective peripheral endovascular interventions.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Ability to provide written informed consent or consent through a legal representative

You may not qualify if:

• Preexisting cognitive impairment (Montreal Cognitive Assessment score below the education-adjusted cutoff) or diagnosed dementia.
• Severe visual or hearing impairment or language barrier precluding reliable delirium assessment.
• Major psychiatric disorders, including schizophrenia or bipolar disorder.
• Contraindications to stellate ganglion block, including local infection at the puncture site, known allergy to local anesthetics, or severe coagulopathy.
• Severe systemic disease, including Child-Pugh C liver cirrhosis, end-stage renal disease (eGFR \<30 mL/min/1.73 m² or dialysis), or NYHA class III-IV heart failure.
• Emergency surgery.
• History of substance abuse

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Gao WB, Wang WH, Zhou ST, Lu ZW, Xiang X, Hu J, Jin TY, Ni CB, Yao M, Ni HD. Efficacy of Repetitive Transcranial Magnetic Stimulation on Postoperative Delirium in Elderly Patients Undergoing Non-Cardiac Major Surgery: A Randomized Controlled Trial. Brain Behav. 2026 Feb;16(2):e71242. doi: 10.1002/brb3.71242.

  PMID: 41612909 BACKGROUND

• Yoo Y, Lee CS, Kim YC, Moon JY, Finlayson RJ. A Randomized Comparison between 4, 6 and 8 mL of Local Anesthetic for Ultrasound-Guided Stellate Ganglion Block. J Clin Med. 2019 Aug 27;8(9):1314. doi: 10.3390/jcm8091314.

  PMID: 31461935 BACKGROUND

• Stevens RA, Stotz A, Kao TC, Powar M, Burgess S, Kleinman B. The relative increase in skin temperature after stellate ganglion block is predictive of a complete sympathectomy of the hand. Reg Anesth Pain Med. 1998 May-Jun;23(3):266-70. doi: 10.1016/s1098-7339(98)90053-0.

  PMID: 9613538 BACKGROUND

• Maldonado JR. Neuropathogenesis of delirium: review of current etiologic theories and common pathways. Am J Geriatr Psychiatry. 2013 Dec;21(12):1190-222. doi: 10.1016/j.jagp.2013.09.005.

  PMID: 24206937 BACKGROUND

• Cerejeira J, Firmino H, Vaz-Serra A, Mukaetova-Ladinska EB. The neuroinflammatory hypothesis of delirium. Acta Neuropathol. 2010 Jun;119(6):737-54. doi: 10.1007/s00401-010-0674-1. Epub 2010 Mar 24.

  PMID: 20309566 BACKGROUND

• Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.

  PMID: 20007989 BACKGROUND

• Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.

  PMID: 29020579 BACKGROUND

• Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

  PMID: 23992774 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Peripheral Arterial Disease

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

loay mohamed Gamal, master

CONTACT

+201017675686; loaygamal94@gmail.com

mohamed mamdouh mohamed, MD

CONTACT

+201011976368; Mamdouh372@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: outcome assessor, and statistician are blinded to treatment allocation. The anesthesiologist performing the study procedure is unblinded and does not participate in postoperative outcome assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09