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).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: loay mohamed Gamal, master
- Telefonnummer: +201017675686
- E-post: loaygamal94@gmail.com
Studer Kontakt Backup
- Navn: mohamed mamdouh mohamed, MD
- Telefonnummer: +201011976368
- E-post: Mamdouh372@med.aun.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Ingen inngripen: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative incidence of postoperative delirium
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Delirium severity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: postoperative 24 hours , 48 hours , 72 hours.
|
by Morphine milligram equivalents (MME) |
postoperative 24 hours , 48 hours , 72 hours.
|
|
Safety and adverse events
Tidsramme: postoperative 24 hours , 48 hours , 72 hours.
|
postoperative 24 hours , 48 hours , 72 hours.
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
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Datoer for studieregistrering
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Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Psykiske lidelser
- Postoperative komplikasjoner
- Patologiske prosesser
- Forvirring
- Nevroatferdsmanifestasjoner
- Nevrokognitive lidelser
- Aterosklerose
- Arteriosklerose
- Arterielle okklusive sykdommer
- Perifere vaskulære sykdommer
- Delirium
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Emergence Delirium
- Perifer arteriell sykdom
- Organiske kjemikalier
- Anilider
- Amides
- Anilinforbindelser
- Aminer
- Ropivakain
Andre studie-ID-numre
- Postoperative Delirium
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