Effect of Preoperative Ultrasound-Guided Stellate Ganglion Block on Postoperative Delirium in Older Adults Undergoing Elective Peripheral Endovascular Intervention
Effect of Preoperative Ultrasound-Guided Stellate Ganglion Block on Postoperative Delirium in Older Adults Undergoing Elective Peripheral Endovascular Interventions: A Randomized Controlled Trial.
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).
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Postoperative delirium is a frequent complication among older adults undergoing surgery and vascular interventions. This study will investigate whether preoperative ultrasound-guided stellate ganglion block can reduce postoperative delirium through modulation of sympathetic activity and potentially inflammatory responses.
Eligible participants aged 60 years or older undergoing elective peripheral endovascular interventions will be randomly allocated in a 1:1 ratio to an active stellate ganglion block group or control group. The active intervention will consist of a right-sided ultrasound-guided stellate ganglion block performed at the C6 level approximately 30 minutes before surgery, using a 22-gauge needle and 5 mL of 0.375% ropivacaine. The control group will receive standard perioperative care and regional anesthesia according to the study protocol, but no stellate ganglion block or sham procedure will be performed
All participants will receive standardized anesthesia consisting of ultrasound-guided combined femoral and sciatic nerve blocks with bupivacaine, supplemented by dexmedetomidine sedation.
The primary outcome will be cumulative incidence of postoperative delirium from postoperative day 1 through postoperative day 3, assessed twice daily using the 3D-CAM. Secondary outcomes will include delirium severity, delirium duration, postoperative pain, opioid consumption, and safety/adverse events.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: loay mohamed Gamal, master
- Telefonnummer: +201017675686
- E-Mail: loaygamal94@gmail.com
Studieren Sie die Kontaktsicherung
- Name: mohamed mamdouh mohamed, MD
- Telefonnummer: +201011976368
- E-Mail: Mamdouh372@med.aun.edu.eg
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Ultrasound-Guided Stellate Ganglion Block
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 |
5 mL of 0.375% ropivacaine administered during ultrasound-guided right stellate ganglion block at the C6 level approximately 30 minutes before surgery. |
|
Kein Eingriff: control group
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cumulative incidence of postoperative delirium
Zeitfenster: postoperative 24 hours , 48 hours , 72 hours.
|
.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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Delirium severity
Zeitfenster: postoperative 24 hours , 48 hours , 72 hours , among participants diagnosed with postoperative delirium
|
the severity of delirium will be graded using Memorial Delirium Assessment Scale (MDAS) |
postoperative 24 hours , 48 hours , 72 hours , among participants diagnosed with postoperative delirium
|
|
Duration of postoperative delirium
Zeitfenster: postoperative 24 hours , 48 hours , 72 hours.
|
Number of postoperative days with a positive 3D-CAM assessment |
postoperative 24 hours , 48 hours , 72 hours.
|
|
Postoperative pain intensity
Zeitfenster: Immediate postoperative period 2 hours 6 hours 12 hours 24 hours
|
Postoperative pain intensity will be assessed by Numerical Rating Scale (NRS) |
Immediate postoperative period 2 hours 6 hours 12 hours 24 hours
|
|
Total postoperative opioid consumption
Zeitfenster: postoperative 24 hours , 48 hours , 72 hours.
|
by Morphine milligram equivalents (MME) |
postoperative 24 hours , 48 hours , 72 hours.
|
|
Safety and adverse events
Zeitfenster: postoperative 24 hours , 48 hours , 72 hours.
|
postoperative 24 hours , 48 hours , 72 hours.
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Psychische Störungen
- Postoperative Komplikationen
- Pathologische Prozesse
- Verwirrtheit
- Neurobehaviorale Manifestationen
- Neurokognitive Störungen
- Atherosklerose
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Periphere Gefäßerkrankungen
- Delirium
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Entstehung Delirium
- Periphere arterielle Verschlusskrankheit
- Organische Chemikalien
- Anilides
- Amides
- Anilinverbindungen
- Amine
- Ropivacain
Andere Studien-ID-Nummern
- Postoperative Delirium
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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