[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658067":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":41,"studyPopulation":30,"armGroups":42,"interventions":53,"overallOfficials":30,"centralContacts":59,"locations":30,"responsibleParty":69,"collaborators":30,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":30,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":30,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":95,"whyStopped":30,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":30},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"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.",[14,18,21,25,28],{"measure":15,"description":16,"timeFrame":17},"Delirium severity","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",{"measure":19,"description":20,"timeFrame":12},"Duration of postoperative delirium","Number of postoperative days with a positive 3D-CAM assessment",{"measure":22,"description":23,"timeFrame":24},"Postoperative pain intensity","Postoperative pain intensity will be assessed by Numerical Rating Scale (NRS)","Immediate postoperative period 2 hours 6 hours 12 hours 24 hours",{"measure":26,"description":27,"timeFrame":12},"Total postoperative opioid consumption","by Morphine milligram equivalents (MME)",{"measure":29,"description":30,"timeFrame":12},"Safety and adverse events",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":36,"maskingDescription":37,"whoMasked":38},"DOUBLE","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.",[39,40],"INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nEligible 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\n\nAll participants will receive standardized anesthesia consisting of ultrasound-guided combined femoral and sciatic nerve blocks with bupivacaine, supplemented by dexmedetomidine sedation.\n\nThe 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\u002Fadverse events.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"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\u002For a relative increase in ipsilateral skin temperature of ≥1.5°C within 15 minutes after injection",[48],"Drug: ropivacaine",{"label":50,"type":51,"description":52,"interventionNames":30},"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",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":30},"DRUG","ropivacaine","5 mL of 0.375% ropivacaine administered during ultrasound-guided right stellate ganglion block at the C6 level approximately 30 minutes before surgery.",[44],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":30,"email":64},"loay mohamed Gamal, master","CONTACT","+201017675686","loaygamal94@gmail.com",{"name":66,"role":62,"phone":67,"phoneExt":30,"email":68},"mohamed mamdouh mohamed, MD","+201011976368","Mamdouh372@med.aun.edu.eg",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Loay Gamal","Dr","100658067","effect-of-preoperative-ultrasound-guided-stellate-ganglion-block-on-postoperative-delirium-in-older-adults-undergoing-elective-peripheral-endovascular-intervention-100658067",false,"NCT07848113","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.","Inclusion Criteria:\n\n1. Age ≥65 years.\n2. Scheduled for elective peripheral endovascular interventions.\n3. American Society of Anesthesiologists (ASA) physical status I-III.\n4. Ability to provide written informed consent or consent through a legal representative\n\nExclusion Criteria:\n\n1. Preexisting cognitive impairment (Montreal Cognitive Assessment score below the education-adjusted cutoff) or diagnosed dementia.\n2. Severe visual or hearing impairment or language barrier precluding reliable delirium assessment.\n3. Major psychiatric disorders, including schizophrenia or bipolar disorder.\n4. Contraindications to stellate ganglion block, including local infection at the puncture site, known allergy to local anesthetics, or severe coagulopathy.\n5. Severe systemic disease, including Child-Pugh C liver cirrhosis, end-stage renal disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or dialysis), or NYHA class III-IV heart failure.\n6. Emergency surgery.\n7. History of substance abuse","ALL","65 Years",{"count":83,"type":84},168,"ESTIMATED","INTERVENTIONAL",[87],"NA","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).",[90,91],"Postoperative Delirium (POD)","Peripheral Arterial Disease",[93,94],"Postoperative delirium","stellate ganglion block","NOT_YET_RECRUITING","2026-09-26",{"date":98,"type":99},"2026-09-29","ACTUAL",{"date":101,"type":84},"2026-10-01",{"date":103,"type":84},"2028-05-01",{"name":5,"class":6}]