About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
ropivacaine
Drug5 mL of 0.375% ropivacaine administered during ultrasound-guided right stellate ganglion block at the C6 level approximately 30 minutes before surgery.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Delirium severity
the severity of delirium will be graded using Memorial Delirium Assessment Scale (MDAS)
Duration of postoperative delirium
Number of postoperative days with a positive 3D-CAM assessment
Postoperative pain intensity
Postoperative pain intensity will be assessed by Numerical Rating Scale (NRS)
Total postoperative opioid consumption
by Morphine milligram equivalents (MME)
Locations
Sponsors and contacts
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